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application & formulation specialist – pharmaceutical r&d equipment

clinical research associate biopharma

AstraZeneca

<div>
 At AstraZeneca, we unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim &ndash; treating, preventing, modifying and even curing complex diseases. With an unwavering belief in following the science, we unleash our curiosity. Investing in key areas, harnessing innovative technologies and taking smart risks. Help to shape the future of healthcare as we take our pipeline from strength to strength. Embrace an environment built on lifelong learning. Never complacent, we seek opportunities to expand our knowledge. The place to build a long-term meaningful career. Here we get to develop and grow &ndash; whether that&rsquo;s working at the leading-edge or on varied stages and molecules. Working on things that have never been done before. In return, when great science comes alive, we have the opportunity to get published. We stand together behind a shared ambition. United by our collective passion for having a positive impact on patients&rsquo; lives. Important work that is both meaningful and fulfilling. With the potential to reach over a billion patients across the globe who are living with these complex diseases.
 
 
 
 Background &amp; Qualifications
 
 
 
 <ul>
 <li>
 University degree, preferably from Healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties),
 </li>
 <li>
 Good level of English,
 </li>
 <li>
 Minimum 1 year of experience in a CRA and/or study coordinator positions
 </li>
 <li>
 Strong communication and negotiation skills,
 </li>
 <li>
 Ability to prioritize and handle multiple tasks,
 </li>
 <li>
 Effective planning and organizational skills with a result-oriented approach,
 </li>
 <li>
 Analytical thinking, critical reasoning ability,
 </li>
 <li>
 Good command of MS Office applications,
 </li>
 <li>
 No restriction to travel,
 </li>
 <li>
 Driving License,
 </li>
 <li>
 No military obligation for male candidates.
 
 
 </li>
 </ul>
 
 Job Description
 
 
 
 <ul>
 <li>
 Perform monitoring and site management activities for phase trials projects to assess the progress of clinical projects at assigned investigative/physician sites
 </li>
 <li>
 Ensure clinical project is conducted, recorded, and reported in accordance with the protocol, Company SOPs, ICH-GCP, and all applicable local and legal requirements.
 </li>
 <li>
 May assume clinical functional leadership tasks are assigned, actions as Lead CRA for project
 </li>
 <li>
 Train, support and advise Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
 </li>
 <li>
 Drive performance at the sites. Proactively identify and ensure timely resolution to study-related issues and escalate them as appropriate.
 </li>
 <li>
 Perform regular Site Quality Risk Assessments and adapt monitoring intensity accordingly during the study.
 </li>
 <li>
 Ensure data query resolution in a timely manner.
 </li>
 <li>
 Work with data management to ensure the robust quality of the collected study data.
 </li>
 <li>
 Collaborate with local MSLs as directed by LSM or line manager.
 
 
 </li>
 </ul>
 
 Why AstraZeneca?
 
 
 
 A high performing team, we work hard to not just meet but go beyond the needs of patients and the wider healthcare industry We leverage our partnerships with external experts across the industry, to create and communicate evidence that changes medical practice. As a partner for many, we effectively communicate complex ideas whilst seeking to understand ever-changing needs and requirements. Our valuable contribution and scientific expertise is responsible for advancing our pipeline and accelerating our pathway to finding a cure. Are you already imagining yourself joining our team? Good, because we can&rsquo;t wait to hear from you.
 
 
 
 Where can I find out more?
 
 
 
 Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
 
 
 Follow AstraZeneca on Instagram https://www.instagram.com/astrazenecaturkiyekariyer/
 
 
 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
</div>

Clinical Research Associate (Biopharma)

IQVIA

<div>
 
 Job Overview
 
 
 
 Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor&rsquo;s requirements.
 
 
 
 Essential Functions
 
 
 
 <ul>
 <li>
 Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations. Responsible for delivery on established targets/measurements.
 </li>
 <li>
 Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate.
 </li>
 <li>
 Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
 </li>
 <li>
 Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
 </li>
 <li>
 Manage the contract amendment lifecycle.
 </li>
 <li>
 Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
 </li>
 <li>
 Assume responsibility for all aspects of legal document and metrics tracking.
 </li>
 <li>
 Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
 </li>
 <li>
 Track all aspects of legal document and metrics. Determine potential needs for contract amendments and manage amendment lifecycle.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in related field
 </li>
 <li>
 3 years&rsquo; experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.
 </li>
 <li>
 Excellent communication skills (both oral and written).
 </li>
 <li>
 Familiarity with healthcare compliance and other relevant guidance
 </li>
 <li>
 Familiarity with clinical research processes.
 
 
 </li>
 </ul>
 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>

Contract Negotiator (FSP) - Turkey

<div>Job Overview 
Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor&rsquo;s requirements.
Essential Functions<ul><li>
Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations. Responsible for delivery on established targets/measurements.</li><li>
Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate.</li><li>
Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.</li><li>
Participate in discussions related to the development of site/investigator budgets aligned with fair market value.</li><li>
Manage the contract amendment lifecycle.</li><li>
Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.</li><li>
Assume responsibility for all aspects of legal document and metrics tracking.</li><li>
Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.</li><li>
Track all aspects of legal document and metrics. Determine potential needs for contract amendments and manage amendment lifecycle.</li></ul>
Qualifications<ul><li>
Bachelor&rsquo;s degree in related field</li><li>
3 years&rsquo; experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.</li><li>
Excellent communication skills (both oral and written).</li><li>
Familiarity with healthcare compliance and other relevant guidance</li><li>
Familiarity with clinical research processes.</li></ul>
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>

Syneos Health

<div>Description
CTA - Istanbul
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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 accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
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 our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<ul><li>
Safeguarding the wellbeing of research subjects in a medical capacity, ensuring that all procedures are conducted with the highest standards of care and safety</li><li>
Reviewing study protocols and executing procedures in alignment with protocols and regulatory, health, and safety standards, ensuring compliance with all relevant guidelines and regulations</li><li>
Recruiting and coordinating communication with clinical trial volunteers and patients, maintaining clear and effective communication throughout the study</li><li>
Following applicable regulations globally and by region, ensuring that all activities are conducted in accordance with local and international standards</li><li>
Collaborating with cross-functional teams to develop study materials, including informed consent forms, study manuals, and other essential documents</li><li>
Monitoring trial progress and addressing any issues that arise during the study, ensuring that all problems are promptly identified and resolved</li><li>
Providing organizational related support or service, typically under supervision, assisting with administrative tasks and other support activities as needed</li><li>
Performing routine tasks with some deviation from standard practice, adapting to changing circumstances and requirements as necessary</li><li>
Utilizing broad knowledge of operational systems and practices gained through extensive experience and/or education, applying this knowledge to improve study processes and outcomes</li></ul>
Qualifications<ul><li>
High school diploma or equivalent required</li><li>
Associate's degree or higher in a related field preferred</li><li>
Minimum of 2 years of experience in clinical operations or a related field; related with CTA tasks</li><li>
Strong understanding of clinical research protocols and regulatory requirements</li></ul>
Certifications<ul><li>
Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred</li><li>
Basic Life Support (BLS) certification required</li></ul>
Necessary Skills<ul><li>
Excellent communication and interpersonal skills</li><li>
Strong organizational and time management abilities</li><li>
Attention to detail and accuracy in documentation</li><li>
Ability to work effectively in a team environment</li><li>
Proficiency in Microsoft Office Suite and clinical trial management software</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
Clinical Trial Assistant Roles within Clinical Operations at the S11 level are responsible for ensuring the safe and effective operations of clinical research studies. This includes safeguarding the wellbeing of research subjects in a medical capacity, reviewing study protocols, and executing procedures in alignment with protocols and regulatory, health, and safety standards. These roles involve recruiting and coordinating communication with clinical trial volunteers and patients, and following applicable regulations globally and by region. Collaboration with cross-functional teams to develop study materials, monitor trial progress, and address any issues that arise during the study is also a key aspect of these roles.Impact and ContributionRoles within Clinical Operations at the S11 level significantly contribute to the success of clinical research studies by ensuring that all operations are conducted safely and effectively. By safeguarding the wellbeing of research subjects and adhering to regulatory standards, these roles help maintain the integrity and reliability of clinical trials. The coordination and communication with clinical trial volunteers and patients ensure smooth and efficient study progress. Collaboration with cross-functional teams enhances the development of study materials and the resolution of any issues, ultimately contributing to the advancement of medical research and the development of new treatments.Core Focus&bull;Safeguarding the wellbeing of research subjects in a medical capacity&bull;Reviewing study protocols and executing procedures in alignment with protocols and regulatory, health, and safety standards&bull;Recruiting and coordinating communication with clinical trial volunteers and patients&bull;Following applicable regulations globally and by region&bull;Collaborating with cross-functional teams to develop study materials&bull;Monitoring trial progress and addressing any issues that arise during the study&bull;Providing organizational related support or service, typically under supervision&bull;Performing routine tasks with some deviation from standard practice&bull;Utilizing broad knowledge of operational systems and practices gained through extensive experience and/or education</div>

CTA - Istanbul

<div>Description
Clinical Trial Manager II - FSP - Turkey
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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 accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
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 our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
Job Responsibilities<ul><li>
Develop, coordinate, and implement Phase 1 clinical research studies at the organization's facilities, ensuring adherence to study protocols and timelines</li><li>
Collaborate with the principal investigator to design study protocols and ensure scientific integrity</li><li>
Liaise between research subjects, client teams, investigators, and clinic operations teams to facilitate smooth communication and coordination</li><li>
Plan logistics and resource usage for clinical trials, including scheduling, staffing, and equipment needs</li><li>
Track study progress in alignment with project milestones, client deliverables, and budget, and provide regular updates to stakeholders</li><li>
Ensure compliance with applicable regulations globally and by region, including Good Clinical Practice (GCP) guidelines</li><li>
Supervise experienced support employees and/or entry-level individual contributors, planning, prioritizing, and directing their tasks to ensure efficient workflow and high-quality output</li><li>
Deliver operational results that have a moderate impact on the immediate achievement of results for the team, contributing to the overall success of the organization</li><li>
Adapt new procedures, techniques, and tools to improve clinical trial processes and outcomes</li><li>
Understand basic management approaches such as work scheduling, prioritizing, coaching, and process execution</li></ul>
Qualifications:<ul><li>
Broad job knowledge in an operational, administrative, and/or specialized field</li><li>
Practical knowledge in managing the execution of processes, projects, and tactics within a team</li><li>
Understanding of the impact of work on related areas</li></ul>
Certifications:<ul><li>
Relevant certifications in clinical trial management or related fields</li></ul>
Necessary Skills:<ul><li>
Strong leadership and management skills</li><li>
Excellent communication and collaboration abilities</li><li>
Ability to plan and prioritize tasks effectively</li><li>
Proficiency in tracking and reporting study progress</li><li>
Knowledge of global and regional regulations for clinical trials</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 the Clinical Trial Management job family at the M23 level are responsible for overseeing the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities. These roles involve collaboration with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and planning logistics and resource usage. Individuals in these roles track study progress in alignment with project milestones, client deliverables, and budget, while ensuring compliance with applicable regulations globally and by region.Impact and ContributionRoles within the Clinical Trial Management job family at the M23 level play a crucial role in the successful execution of clinical research studies, directly impacting the organization's ability to deliver high-quality, timely, and compliant research outcomes. By effectively managing resources, coordinating teams, and ensuring adherence to protocols, these roles contribute to the advancement of medical knowledge and the development of new treatments. The strategic vision and tactical direction provided by individuals in these roles help achieve operational results that have a moderate impact on the immediate achievement of results for the team.Core Focus&bull;Supervising experienced support employees and/or entry-level individual contributors&bull;Delivering operational results that have a moderate impact on the immediate achievement of results for the team&bull;Utilizing broad job knowledge in an operational, administrative, and/or specialized field&bull;Adapting new procedures, techniques, tools, etc. Understanding basic management approaches such as work scheduling, prioritizing, coaching, and process execution</div>

Clinical Trial Manager II - FSP - Turkey

<div>Description
Sr CRA I - FSP - Turkey - Homebased
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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 accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
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 our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.</li><li>
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.</li></ul>
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 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):
</li><li>Assesses site processes
</li><li>Conducts Source Document Review of appropriate site source documents and medical records
</li><li>Verifies required clinical data entered in the case report form (CRF)is accurate and complete via review of site source documents and medical records
</li><li>Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
</li><li>Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
</li><li>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>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 project 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, and may, with supervision, 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 training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
</li><li>May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.
</li><li>For Real World Late Phase (RWLP), the Sr. CRA I will use the businesscard title of Sr. Site Management Associate I. Additional responsibilities include:
</li><li>Site support throughout the study lifecycle from site identification through close out
</li><li>Knowledge of local requirements for real world late phase study designs
</li><li>Chart abstraction activities and data collection
</li><li>As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff
</li><li>Identify and communicate out of scope activities to Lead CRA/Project Manager
</li><li>Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
</li><li>Identify operational efficiencies and process improvements
</li><li>Develop country level informed consent forms
</li><li>Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
</li><li>Participate in bid defense meetings</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. Basic 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.</div>

Sr CRA I - FSP - Turkey - Homebased

Align Technology

<div>
 
 Department:
 
 Clinical
 
 
 
 Location:
 
 EMEA-Turkey
 
 
 
 Description
 
 
 
 The function is responsible for clinical education, communication, and support of both external and internal customers. Supports practicing orthodontists and general dentists in the resolution of case-specific clinical issues related to the Invisalign and iTero systems. Provides unbiased medical information about the company&rsquo;s products to increase brand awareness and support safe product use among the medical community and customers. Reviews promotional advertising for accuracy and completeness of medical information. Provides medical expertise, training and guidance to marketing and commercial teams and ensures they have sufficient clinical knowledge and information regarding the company's products. Drives adoption and growth, builds clinical confidence of customers through education on Align&rsquo;s clinical protocols and ClinCheck software program. Remains up to date with scientific trends and knowledge. Supports University and Research programs, creates, and maintains clinical education content, and builds relationships with target key opinion leaders.
 
 
 
 Key Responsibilities
 
 
 
 Your mission is to provide customers the best clinical support and education
 
 
 This position is mainly responsible for clinical confidence and case growth across Invisalign product portfolio through clinical education and support to customers. The process includes interaction and communication with private-practicing orthodontists and treatment coordinators related to case specific issues, ClinCheck quality and troubleshooting. Focus will be on clinical education as well as troubleshooting clinical issues for customers. In addition, other duties will include support with day to day needs of education events, University programmes. You will be field based in the assigned area and work remotely, including 60-70% customer visits in the area.
 
 
 <ul>
 <li>
 Conduct field visits with support or semi-independently at least 70% of the time
 </li>
 <li>
 Continue to build knowledge of business, products/services, the market, clinical or account needs
 </li>
 <li>
 Provide clinical support &amp; education to orthodontists, dentists in private clinics as well as might do within DSO organizations and Universities
 </li>
 <li>
 Plans &amp; executes with support or semi-independently interactive roundtables with customers to drive case discussion &amp; peer-to-peer networking / learning
 </li>
 <li>
 Work with moderately complex territory/assigned accounts, account management processes
 </li>
 <li>
 Is beginning to plan own territory or account approach and monitor resources
 </li>
 <li>
 Requires more resources, training and support to contribute on independent level
 
 
 </li>
 </ul>
 
 You will do mainly by
 
 
 
 
 Clinical Support Activities
 
 
 
 <ul>
 <li>
 Providing clinical customer support to orthodontists and general dentists in the areas of case evaluation, ClinCheck support as well as clinical troubleshooting
 </li>
 <li>
 Investigating and Analyzing of Clinical-related customer inquiries, complaints and adverse events.
 </li>
 <li>
 Ensuring timely resolution to customer contact issue whether in-bound or out-bound.
 </li>
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 Drive and accelerate clinical confidence for selected groups of doctors via specifically designed educational programs in close coordination with Customer Support and Sales Teams.
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 Clinical education activities; for live and online events:
 </li>
 <ul>
 <li>
 Coordinating with clinical speaker
 </li>
 <li>
 Presenting clinical content
 </li>
 </ul>
 <li>
 Congress:
 </li>
 <ul>
 <li>
 Coordinate with clinical speaker
 </li>
 <li>
 Present clinical contents
 </li>
 <li>
 On booth clinical support and education activities
 </li>
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 Field visits &ndash; high tier Drs + key accounts, Supporting and delivering university training
 </li>
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 Additional activities - Speaker Management, DSO &ndash; education delivery, Segmentation Lead/Coordinator, Creating educational content (in conjunction with Education team)
 
 </li>
 </ul>
 </ul>
 
 Skills, Knowledge &amp; Expertise
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree preferred and/or equivalent experience required (dentistry). Possess negotiation skills, challenger approach as well as didactical/presentation and facilitator skills.
 </li>
 <li>
 1-3 years outside of directly related experience or joining from dental practice with no direct commercial experience.
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 <li>
 Experience in customer relations in medical / dental related areas or in an international call center environment.
 </li>
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 Good written and verbal communication skills in English.
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 30% of the time home based
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 Travel up to 70% of the time across Istanbul/Turkey
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 The remaining time will be spent on activities of clin checks and planning
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 The ability to flourish in a young international company experiencing significant growth (i.e. roll up sleeves approach and able to deal with ambiguity).
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 The ideal candidate should possess strong interpersonal, listening and persuasive communication skills to give the best advices to our customers. You naturally strive for the best performance and you have the willingness to learn.
 </li>
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 Additionally, you are a good team player, dynamic, optimistic, accurate, result oriented, hard-working and creative.
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 Structures and manages the execution of project/program tasks with general supervision and little guidance and recommends new approaches
 
 
 </li>
 </ul>
 
 Applicant Privacy Policy
 
 
 
 Review our
 
 Applicant Privacy Policy
 
 for additional information.
 
 
 
 Equal Opportunity Statement
 
 
 
 Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
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