r&d product development associate engineer / r&d project manager

research & development specialist/executive

legal billing & operations analyst - asset resolution (türkiye)

r&d product development associate engineer / r&d project manager Jobs in Turkey

audit associate (remote, usa-based) Jobs in Turkey

audit associate (remote, usa-based)

healthcare researcher

hr data analytics specialist Jobs in Turkey

hr data analytics specialist

research & development specialist/executive Jobs in Turkey

clinical research associate ii

PSI CRO

<div>Company Description 
We are the company that cares &ndash; for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. 
Job Description 
As a Clinical Research Associate II, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets, and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects&rsquo; rights, safety and well-being and quality of data compliance.
Hybrid role in Ankara, Turkey (6 months office-based, followed by a hybrid work model)
Your responsibilities will include:<ul><li>
Preparation, conduct, and reporting of all types of monitoring visits</li><li>
Supporting quality control, such as compliance monitoring and reports review</li><li>
Contact for clinical investigators, vendors and support services in regard to study progress</li><li>
Proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and trial supplies at sites</li><li>
Delivering training of investigators, site staff and project teams</li><li>
Be involved in site identification process and feasibility research</li><li>
Support to Regulatory Affairs in procurement of site regulatory documents</li><li>
Preparation and delivering of presentations at Investigator&rsquo;s Meetings</li><li>
Maintenance of study-specific automated tracking systems</li><li>
Preparation for and attendance at company&rsquo;s audits; resolution of audit findings</li></ul> 

Qualifications 
<ul><li>
Degree in Life Sciences (or similar), or an equivalent combination of education, training &amp; experience</li><li>
1 year of independent on-site monitoring experience</li><li>
Experience in all types of monitoring visits in Phase II and/or III</li><li>
Native Turkish and full working proficiency in English (B2)</li><li>
Experience supporting Oncology studies is beneficial, but not essential</li><li>
Proficiency in MS Office applications</li><li>
Ability to plan, multitask and work in a dynamic team environment</li><li>
Communication, collaboration, and problem-solving skills</li><li>
As you will be monitoring multiple sites, you must have a valid driver's license, and the ability to travel.</li></ul> 

Additional Information 
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.</div>

Clinical Research Associate II

サイネオス・ヘルス

<div><div><div>Updated: Yesterday 
Location: Nida Kule Iş Merkezi G&ouml;ztepe, 34, Turkey 
Job ID: 25107370
<div><div>Not ready to apply? 
Join our Talent Network
</div></div><div>Description
CRA II - FSP<div>
Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. 
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver &ndash; for one another, our customers, and, most importantly, for those in need.
 
 
Discover what your 25,000 future colleagues already know:
 
 
Why Syneos Health 
<ul><li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>We are committed to building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.</li></ul></div>
Job Responsibilities<ul><li>
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.</li><li>
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li><li>
Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.</li><li>
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li><li>
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.</li><li>
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.</li><li>
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.</li><li>
May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements</li><li>
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.</li><li>
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.</li><li>
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection 
Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience</li><li>
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements</li><li>
Must demonstrate good computer skills and be able to embrace new technologies</li><li>
Excellent communication, presentation and interpersonal skills</li><li>
Ability to manage required travel of up to 75% on a regular basis</li><li>
US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.</li></ul>
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.</div></div></div></div><div></div>

CRA II - FSP

<div><div><div>Updated: Yesterday 
Location: Nida Kule Iş Merkezi G&ouml;ztepe, 34, Turkey 
Job ID: 25107030
<div><div>Not ready to apply? 
Join our Talent Network
</div></div><div>Description
CRA II - Fully Homebased - Open for any City in Turkey - FSO/FSP<div>
Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. 
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver &ndash; for one another, our customers, and, most importantly, for those in need.
 
 
Discover what your 25,000 future colleagues already know:
 
 
Why Syneos Health 
<ul><li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>We are committed to building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.</li></ul></div>
Job Responsibilities<ul><li>
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.</li><li>
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li><li>
Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.</li><li>
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li><li>
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.</li><li>
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.</li><li>
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.</li><li>
May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements</li><li>
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.</li><li>
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.</li><li>
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection 
Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience</li><li>
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements</li><li>
Must demonstrate good computer skills and be able to embrace new technologies</li><li>
Excellent communication, presentation and interpersonal skills</li><li>
Ability to manage required travel of up to 75% on a regular basis</li><li>
US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.</li></ul>
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.</div></div></div></div><div></div>

CRA II - Fully Homebased - Open for any City in Turkey - FSO/FSP

<div><div><div>Updated: Yesterday 
Location: Nida Kule Iş Merkezi G&ouml;ztepe, 34, Turkey 
Job ID: 25107463
<div><div>Not ready to apply? 
Join our Talent Network
</div></div><div>Description
Site Care Partner I (SrCRA) - FSP, Sponsor Dedicated<div>
Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. 
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver &ndash; for one another, our customers, and, most importantly, for those in need.
 
 
Discover what your 25,000 future colleagues already know:
 
 
Why Syneos Health 
<ul><li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li><li>We are committed to building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.</li></ul></div>
Job Responsibilities<ul><li>
Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.</li><li>
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.</li><li>
Per the Clinical Monitoring/Site Management Plan (CMP/SMP):Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records 
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines 
Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.</li><li>
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.</li><li>
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.</li><li>
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and action items to resolution.</li><li>
Understands project scope, budgets, and timelines for own and others&rsquo; activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.</li><li>
May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.</li><li>
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.</li><li>
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.</li><li>
May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned. May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings.</li><li>
For Real World Late Phase (RWLP), the Sr. CRA II will use the business card title of Sr.Site Management Associate II. Additional responsibilities include: 
Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs 
Chart abstraction activities and data collection 
As required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staff 
The SMA II may be requested to train junior staff 
Identify and communicate out of scope activities to Lead CRA/Project Manager 
Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. 
Identify operational efficiencies and process improvements 
Develop study and country level informed consent forms 
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared 
Participate in bid defense meetings 
Provide input into Requests for Proposals (RFPs), scope and budgeting. Develop site management strategy. 
Participate in Case Report Form design and edit check development.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience</li><li>
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements</li><li>
Must demonstrate good computer skills and be able to embrace new technologies</li><li>
Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.</li><li>
Ability to manage required travel of up to 75% on a regular basis</li></ul>
Get to know Syneos Health 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
Roles within Clinical Monitoring/CRA job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.</div></div></div></div><div></div>

Site Care Partner I (SrCRA) - FSP, Sponsor Dedicated

MSD Türkiye

<div>
 
 Job Description
 
 
 
 
 Business &amp; Data Analyst &ndash; Automation, Analytics &amp; AI (BA &ndash; AA &amp; AI)
 
 
 
 The Business Analyst &ndash; Automation, Analytics &amp; AI (BA &ndash; AA &amp; AI) supports the identification, delivery, and sustainment of country-level automation, analytics, and AI solutions that enhance clinical trial operations. Working under the guidance of the Clinical Research Director (CRD) and in close collaboration with the RRO Automation Analytics &amp; AI Lead (RAAI Lead) and Senior Business Analysts, the role assists with business case preparation, data analysis, dashboard/report building, workflow documentation, solution testing, training, and user support.
 
 
 The BA &ndash; AA &amp; AI helps ensure solutions are compliant, adopted, and continuously improved and may be involved in supporting alignment and scalability for regional and global solutions. As needed, the BA &ndash; AA &amp; AI may also support initiatives driven by Regional Operations teams, such as Global Site Agreements (GSA), Global Trial Optimization (GTO), Global Sites Budgets and Payments (GSBP) and Essential Document Management (EDM).
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Intake &amp; analysis support
 </li>
 <li>
 Assist in compiling business cases, gathering requirements, mapping processes, and documenting user stories and acceptance criteria.
 </li>
 <li>
 Conduct data exploration and prepare baseline metrics to define problem statements and expected benefits.
 </li>
 <li>
 Verify with relevant central repositories and teams if there are similar tools to avoid duplication; summarize reuse opportunities and recommendations for the Sr. BA &ndash; AA &amp; AI and RAAI Lead.
 </li>
 <li>
 Solution build &amp; testing
 </li>
 <li>
 Build and maintain country dashboards and basic automations under supervision using approved platforms.
 </li>
 <li>
 Prepare test scripts, perform user acceptance testing (UAT) coordination, and document outcomes; support validation and release documentation.
 </li>
 <li>
 Support configuration and minor enhancements; triage user feedback and escalating defects/issues as needed.
 </li>
 <li>
 Reporting &amp; metrics
 </li>
 <li>
 Produce routine operational reports and Key Performance Indicators (KPI) dashboards; maintain data definitions and refresh cadence.
 </li>
 <li>
 Track solution performance metrics (e.g., adoption, data quality, cycle time) and prepare updates for stakeholders.
 </li>
 <li>
 Compliance &amp; change support
 </li>
 <li>
 Ensure adherence to ICH GCP, Company policies, and local regulations in documentation and solution usage.
 </li>
 <li>
 Support change management activities (training materials, user guides, quick reference content) and deliver end-user training sessions.
 </li>
 <li>
 Collaboration
 </li>
 <li>
 Collaborate with country, regional and headquarters teams, such as Sr. BA - AA &amp; AI / RAAI Lead, and Global Clinical Data Integration (GCDI) / Information Technology (IT) partners; share learnings and templates with peers.
 
 
 </li>
 </ul>
 Extend of Travel Up to 5-10% of working time
 
 
 
 Required Education And Experience
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in life science discipline, business analytics, computing science, engineering, or related field, with 2 years of hands-on experience in data analysis, process improvement, or technology-enabled projects (including exposure to automation platforms, analytics tools, or AI frameworks), or
 </li>
 <li>
 An associate degree or equivalent post‑secondary qualification in a life science discipline, business analytics, computing science, engineering, or related field, combined with a minimum of 4 years of relevant hands-on experience in data analysis, process improvement, or technology-enabled projects (including exposure to automation platforms, analytics tools, or AI frameworks)
 
 
 </li>
 </ul>
 
 Preferred Experience
 
 
 
 <ul>
 <li>
 Exposure to clinical research operations or adjacent functions.
 </li>
 <li>
 Experience with Business Intelligence (BI) tools (e.g., Power BI/Tableau) and basic data wrangling (Excel/PowerQuery/DAX; introductory Structured Query Language (SQL)).
 </li>
 <li>
 Familiarity with workflow documentation and testing/UAT practices.
 </li>
 <li>
 Internships or project work in healthcare/life sciences/regulatory environments desirable.
 
 
 </li>
 </ul>
 
 Required Knowledge, Skills And Abilities
 
 
 
 <ul>
 <li>
 Business analysis skills Ability to gather and document requirements, translate business needs into data or solution specifications, and support testing and validation activities.
 </li>
 <li>
 Data literacy ability to analyze datasets, build reports, and visualize metrics; attention to data quality.
 </li>
 <li>
 Technical aptitude hands-on with Excel and at least one BI tool; foundational understanding of automation platforms and AI-assisted tools, with willingness to learn approved platforms.
 </li>
 <li>
 Organization &amp; communication clear written/verbal English; structured documentation; effective collaboration in a matrixed setting.
 </li>
 <li>
 Compliance awareness basic understanding of operating in regulated environments and adherence to procedures.
 </li>
 <li>
 Learning mindset proactive, curious, and coachable; embracing feedback and continuous improvement.
 
 
 </li>
 </ul>
 
 Required Skills
 
 
 
 Automation Framework Design, Business Analysis, Business Intelligence (BI), Clinical IT, Clinical Research, Good Clinical Data Management Practice (GCDMP), Operational Acceptance Testing (OAT), Test Scripts, User Acceptance Testing (UAT), User Feedback
 
 
 
 Preferred Skills
 
 
 
 Current Employees apply HERE
 
 
 Current Contingent Workers apply HERE
 
 
 
 Search Firm Representatives Please Read Carefully
 
 
 
 Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
 
 
 
 Employee Status
 
 
 
 Regular
 
 
 
 Relocation
 
 
 
 
 VISA Sponsorship
 
 
 
 
 Travel Requirements
 
 
 
 
 Flexible Work Arrangements
 
 
 
 Hybrid
 
 
 
 Shift
 
 
 
 
 Valid Driving License
 
 
 
 
 Hazardous Material(s)
 
 
 
 
 Job Posting End Date
 
 
 
 05/12/2026
 
 
 <ul>
 <li>
 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
 
 
 </li>
 </ul>
 
 Requisition ID
 
 R395941
</div>

Business & Data Analyst – Automation, Analytics & AI

<div>Job Description
Business &amp; Data Analyst &ndash; Automation, Analytics &amp; AI (BA &ndash; AA &amp; AI) 
The Business Analyst &ndash; Automation, Analytics &amp; AI (BA &ndash; AA &amp; AI) supports the identification, delivery, and sustainment of country-level automation, analytics, and AI solutions that enhance clinical trial operations. Working under the guidance of the Clinical Research Director (CRD) and in close collaboration with the RRO Automation Analytics &amp; AI Lead (RAAI Lead) and Senior Business Analysts, the role assists with business case preparation, data analysis, dashboard/report building, workflow documentation, solution testing, training, and user support. 
The BA &ndash; AA &amp; AI helps ensure solutions are compliant, adopted, and continuously improved and may be involved in supporting alignment and scalability for regional and global solutions. As needed, the BA &ndash; AA &amp; AI may also support initiatives driven by Regional Operations teams, such as Global Site Agreements (GSA), Global Trial Optimization (GTO), Global Sites Budgets and Payments (GSBP) and Essential Document Management (EDM). 
Key Responsibilities:<ul><li>Intake &amp; analysis support</li></ul>
o Assist in compiling business cases, gathering requirements, mapping processes, and documenting user stories and acceptance criteria.
o Conduct data exploration and prepare baseline metrics to define problem statements and expected benefits.
o Verify with relevant central repositories and teams if there are similar tools to avoid duplication; summarize reuse opportunities and recommendations for the Sr. BA &ndash; AA &amp; AI and RAAI Lead.<ul><li>Solution build &amp; testing</li></ul>
o Build and maintain country dashboards and basic automations under supervision using approved platforms.
o Prepare test scripts, perform user acceptance testing (UAT) coordination, and document outcomes; support validation and release documentation.
o Support configuration and minor enhancements; triage user feedback and escalating defects/issues as needed.<ul><li>Reporting &amp; metrics</li></ul>
o Produce routine operational reports and Key Performance Indicators (KPI) dashboards; maintain data definitions and refresh cadence.
o Track solution performance metrics (e.g., adoption, data quality, cycle time) and prepare updates for stakeholders.<ul><li>Compliance &amp; change support</li></ul>
o Ensure adherence to ICH GCP, Company policies, and local regulations in documentation and solution usage.
o Support change management activities (training materials, user guides, quick reference content) and deliver end-user training sessions.<ul><li>Collaboration</li></ul>
o Collaborate with country, regional and headquarters teams, such as Sr. BA - AA &amp; AI / RAAI Lead, and Global Clinical Data Integration (GCDI) / Information Technology (IT) partners; share learnings and templates with peers.
Extend of Travel: Up to 5-10% of working time
Required Education and Experience:<ul><li>
Bachelor&rsquo;s degree in life science discipline, business analytics, computing science, engineering, or related field, with 2 years of hands-on experience in data analysis, process improvement, or technology-enabled projects (including exposure to automation platforms, analytics tools, or AI frameworks), or</li><li>
An associate degree or equivalent post‑secondary qualification in a life science discipline, business analytics, computing science, engineering, or related field, combined with a minimum of 4 years of relevant hands-on experience in data analysis, process improvement, or technology-enabled projects (including exposure to automation platforms, analytics tools, or AI frameworks)</li></ul> 
Preferred Experience:<ul><li>
Exposure to clinical research operations or adjacent functions.</li><li>
Experience with Business Intelligence (BI) tools (e.g., Power BI/Tableau) and basic data wrangling (Excel/PowerQuery/DAX; introductory Structured Query Language (SQL)).</li><li>
Familiarity with workflow documentation and testing/UAT practices.</li><li>
Internships or project work in healthcare/life sciences/regulatory environments desirable.</li></ul> 
Required Knowledge, Skills and Abilities:<ul><li>
Business analysis skills: Ability to gather and document requirements, translate business needs into data or solution specifications, and support testing and validation activities.</li><li>
Data literacy: ability to analyze datasets, build reports, and visualize metrics; attention to data quality.</li><li>
Technical aptitude: hands-on with Excel and at least one BI tool; foundational understanding of automation platforms and AI-assisted tools, with willingness to learn approved platforms.</li><li>
Organization &amp; communication: clear written/verbal English; structured documentation; effective collaboration in a matrixed setting.</li><li>
Compliance awareness: basic understanding of operating in regulated environments and adherence to procedures.</li><li>
Learning mindset: proactive, curious, and coachable; embracing feedback and continuous improvement.</li></ul>
Required Skills:
Automation Framework Design, Business Analysis, Business Intelligence (BI), Clinical IT, Clinical Research, Good Clinical Data Management Practice (GCDMP), Operational Acceptance Testing (OAT), Test Scripts, User Acceptance Testing (UAT), User Feedback
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully 
Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/12/2026<ul><li>A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. 
</li></ul> 
Requisition ID:R395941</div>

IQVIA

<div>Istanbul, Turkey | Full time | Home-based | R1535388</div>
 <div><div>To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.</div><div>
Responsabilities:</div><ul><li>
Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.</li><li>
Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies</li><li>
Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.</li><li>
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.</li><li>
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.</li><li>
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.</li><li>
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.</li><li>
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.</li><li>
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant Sponsor SOPs and local regulations.</li><li>
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with Sponsor SOPs.</li><li>
Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).</li><li>
Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.</li><li>
Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.</li><li>
Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.</li><li>
Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.</li><li>
Proactively identifies risks and facilitates resolution of complex study problems and issues.</li><li>
Organises regular Local Study Team meetings on an agenda driven basis.</li><li>
Actively works towards achieving good personal relationships with all Local Study Team members, sites&rsquo; staff and global stakeholders.</li><li>
Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.</li><li>
Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.</li><li>
Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.</li><li>
Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.</li><li>
Plans and leads National Investigator meet Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.</li><li>
Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.</li><li>
Provides input to process development and improvement.</li><li>
Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.</li><li>
Updates Line Managers about the performance of the CRAs/CSAs.</li><li>
Ensures that study activities at country level comply with local policies and code of ethics.</li><li>
Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.</li><li>
Ensures compliance with Sponsor&acute;s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).</li><li>
Collaborates with local Medical Affairs team.</li><li>
Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.</li></ul><div>
Requirements:</div><ul><li>
Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).</li><li>
Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).</li><li>
Good knowledge of international guidelines ICH GCP as well as relevant local regulations.</li><li>
Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.</li><li>
Good medical knowledge and ability to learn relevant Sponsor Therapeutic Areas</li><li>
Good knowledge of the Drug Development Process.</li><li>
Excellent understanding of the Clinical Study Process including monitoring.</li><li>
Very good understanding of the Study Drug Handling Process and the Data Management Process.</li><li>
Excellent project management skills.</li><li>
Excellent team building and interpersonal skills, organizational skill and verbal and written communication skills</li><li>
Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills.</li><li>
Excellent knowledge of spoken and written English and local languages.</li><li>
Good ability to learn and to adapt to work with IT systems.</li><li>
Ability to travel nationally and internationally as required</li></ul><div>
&quot;Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered&rdquo;.</div><div>
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com</div><div>
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.</div></div>

Local Study Associate Director - Sponsor Dedicated (m/w/d)

Explore 102+ Clinical research associate ii in Turkey this May. Find roles across top companies and apply now to boost your career.

102 clinical research associate ii jobs In Turkey

Clinical Research Associate II

CRA II - FSP

CRA II - Fully Homebased - Open for any City in Turkey - FSO/FSP

Site Care Partner I (SrCRA) - FSP, Sponsor Dedicated

Business & Data Analyst – Automation, Analytics & AI

Business & Data Analyst – Automation, Analytics & AI

Local Study Associate Director - Sponsor Dedicated (m/w/d)