Qureos Mentor

Syneos Health

<div>Description
Senior Statistical Programmer
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>
Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.</li><li>
Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).</li><li>
Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.</li><li>
Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.</li><li>
Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.</li><li>
Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted.</li><li>
Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.</li><li>
Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Transfers deliverables. Performs other work-related duties as assigned.</li><li>
Minimal travel may be required.</li></ul>
Qualifications:<ul><li>
Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.</li><li>
Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.</li><li>
Excellent written and verbal communication skills.</li><li>
Ability to read, write, speak and understand English.</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 Statistical Programming job family are responsible for developing programs and providing statistical programming support for statisticians or for client or business use to address needs for sourcing, organizing (creating statistical tables, listings, and graphs), and interpreting complex data sets utilizing codes and programs. This includes developing codes that create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions geared toward increasing productivity.Impact and ContributionIndividual 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>

Senior Statistical Programmer

<div>Description
Senior Statistical Programmer(SDTM)- Hyderabad/ Gurugram -Hybrid
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>
Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.</li><li>
Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).</li><li>
Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.</li><li>
Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.</li><li>
Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.</li><li>
Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted.</li><li>
Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.</li><li>
Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Transfers deliverables. Performs other work-related duties as assigned.</li><li>
Minimal travel may be required.</li></ul>
Qualifications:<ul><li>
Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and 5+ years of Clinical SAS programming experience.</li><li>
Extensive programming (minimum 5years) experience in SAS, end to end SDTM programming- aCRF, SDTM dataset, specification, Pinnacle 21, reviewers guide.</li><li>
Must have sting experience of Base SAS, Advance SAS programming</li><li>
Excellent written and verbal communication skills.</li><li>
Ability to read, write, speak and understand English.</li><li>
Good to have experience of FSO environment</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 Statistical Programming job family are responsible for developing programs and providing statistical programming support for statisticians or for client or business use to address needs for sourcing, organizing (creating statistical tables, listings, and graphs), and interpreting complex data sets utilizing codes and programs. This includes developing codes that create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions geared toward increasing productivity.Impact and ContributionIndividual 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>

Senior Statistical Programmer(SDTM)- Hyderabad/ Gurugram -Hybrid

<div>Description
Senior CRA - FSP - Based in KSA - Phase 2, Phase 3 experience is required
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<h1 class="jobSectionHeader">
Senior CRA - FSP (Single Sponsor)</h1><h1 class="jobSectionHeader">
Phase 2, Phase 3 experience is required</h1><h1 class="jobSectionHeader">
ONLY CANDIDATES FROM KSA WHO HAS VALID WORKING VISA</h1><ul><li>
Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms</li><li>
Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates</li><li>
Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials</li><li>
Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues</li><li>
Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans</li><li>
Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct</li></ul>
Qualifications:<ul><li>
Bachelor's degree in a related field or equivalent experience</li><li>
Minimum of 2-4 years of experience in clinical research monitoring</li><li>
Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements</li><li>
Excellent communication and interpersonal skills</li><li>
Ability to work independently and manage multiple priorities</li><li>
Proficiency in using clinical trial management systems and other relevant software</li></ul>
Certifications:<ul><li>
Certified Clinical Research Associate (CCRA) or equivalent certification preferred</li></ul>
Necessary Skills:<ul><li>
Attention to detail and strong analytical skills</li><li>
Problem-solving abilities and critical thinking</li><li>
Ability to work effectively in a team environment</li><li>
Strong organizational and time management skills</li><li>
Proficiency in Microsoft Office Suite</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 at the P21 level are responsible for ensuring that clinical research studies are 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. These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, and may manage two or fewer employees. 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.Impact and ContributionRoles within Clinical Monitoring/CRA job family at the P21 level have a significant impact on the quality and integrity of clinical research studies. By ensuring adherence to clinical practices and protocols, these roles contribute to the reliability and validity of study results. They play a crucial role in the development and implementation of monitoring tools and procedures, which enhance the overall efficiency and effectiveness of clinical trials. Their contributions are essential for advancing medical knowledge and improving patient outcomes.Core Focus&bull;Conduct thorough on-site and remote monitoring of clinical research studies&bull;Develop and implement tools, procedures, and processes to ensure quality monitoring&bull;Manage defined components of projects or processes within their area of responsibility&bull;Utilize practical knowledge of a professional area, typically obtained through education combined with experience&bull;Maintain high standards of clinical practice and ensure the success of clinical trials</div>

Senior CRA - FSP - Based in KSA - Phase 2, Phase 3 experience is required

<div>Description
Safety &amp; PV Specialist I
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>
Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and testsCompiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.</li><li>
Maintains safety tracking for assigned activities.</li><li>
Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.</li><li>
Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.</li><li>
Manual recoding of un-recoded product and substance terms arises from ICSRs.</li><li>
Identification and management of duplicate ICSRs.</li><li>
Activities related to SPOR / IDMP.</li><li>
Quality review of ICSRs.</li><li>
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.</li><li>
Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.</li><li>
Fosters constructive and professional working relationships with all project team members, internal and external.</li><li>
Participates in audits as required/appropriate.</li><li>
Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.</li><li>
Safety Database systems and knowledge of medical terminology required.</li><li>
Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.</li><li>
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.</li><li>
Ability to work independently and in a team environment.</li><li>
Excellent communication and interpersonal skills, both written and spoken.</li><li>
Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.</li><li>
Detail oriented with a high degree of accuracy and ability to meet deadlines.</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 Pharmacovigilance &amp; Safety job family are responsible for providing expertise on pharmacovigilance services. This includes participating in all aspects of the medical safety team's involvement in assigned trials, such as performing medical review and clarification of trial-related Adverse Events, providing aggregate reviews of safety information, and serving as an internal consultant to pharmacovigilance case processing teams. Provides and contributes trends and safety signal detection and risk management assessment and provides safety support to the clinical development teams.Impact and ContributionIndividual 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. Entry to developing individual contributor. Delivers work of limited scope, typically smaller, less complex projects. Requires theoretical knowledge of a professional area, typically obtained through education and/or prior experience.</div>

Safety & PV Specialist I

<div>Description
Regulatory Consultant/Sr. Consultant - RIM/Veeva Business Analyst (US timeshift)
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
General Responsibilities:<ul><li>
Look for system/process-focused analysts with RIM/Veeva experience.</li><li>
Excellent communication and stakeholder management skills.</li><li>
Master&rsquo;s degree with overall 8+ years&rsquo; experience</li><li>
Experience in system requirement gathering, validation, and user acceptance testing.</li><li>
Ability to collaborate across cross-functional teams (Reg Ops, IT, Process Development etc).</li></ul>
Note:<ul><li>
Exclude candidates whose experience is limited to regulatory publishing/submissions.</li><li>
Availability in EST timezone for collaboration purposes.</li></ul>
Core Responsibilities:<ul><li>
Act as the primary liaison between Regulatory Operations teams and IT/Tool Management teams.</li><li>
Focus on technology enablement and process optimization.</li><li>
Gather and document requirements from key users (business partners, RIM superusers, technical leads).</li><li>
Ensure requirements are maintained and updated in alignment with business needs.</li><li>
Collaborate with DTE and Validation teams.</li><li>
Support user testing activities, including preparation of test scripts and execution oversight.</li><li>
Serve as SME for RIM systems.</li><li>
Provide guidance, communication, and training to users on business tools and processes.</li><li>
Work closely with IT and process development teams to manage RIM system enhancements.</li><li>
Collaboration with global teams to coordinate system inputs, validate data, resolve missing fields or gaps, and support end-to-end system workflows.</li><li>
Contribute to continuous improvement initiatives.</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>

Regulatory Consultant/Sr. Consultant - RIM/Veeva Business Analyst (US timeshift)

<div>Description
CRA II/SCRA, Remote Based- Multi Sponsor
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>
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.</li><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.</li></ul>
Qualifications:<ul><li>
Fluency in English and Turkish essential</li><li>
Experience in Oncology as Therapeutic Area essential</li><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 ContributionIndividual 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>

CRA II/SCRA, Remote Based- Multi Sponsor

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