CVS Health Clinical Source Documentation and User Acceptance Testing Manager in Wellesley, Massachusetts
The Clinical Source Documentation and User Acceptance Testing Manager is responsible for leading the study source document drafts, revisions, and quality controls. This includes creating source document and facilitating its review through the department end users in compliance with the study Protocol, HIPAA, GDP, CFR, ICH-GCP and site Standard Operating Procedures and Work Instructions.This role will:• Adhere to the established Standard Operating Procedures and Work Instructions when performing quality control review of completed electronic source documents• Knowledge of all awarded Protocols and applicable supporting manuals (e.g., pharmacy, lab, ECG, etc.) to create source documents• Participate in study related meetings including but not limited to study award meetings, planning meetings, screening trainings, protocol trainings, and site initiation visits• Read and understand each assigned Protocol• Build source document study design specifications• Design and maintain source documents in compliance with proper safety and emergency policies and procedures• Manage source document review from End Users • Escalate any Protocol discrepancies noted or lack of Protocol clarity to the Study Manager or Sponsor resolution prior to finalizing source document• Address all End User findings and make changes as applicable• Track general findings from source review for future improvement• Format all source document pages for final printing/publishing• Finalize all source documents based on End User approvals• Maintain an open line of communication on daily and weekly basis with team and other department members• Escalate any critical or major findings or trends from all quality control review
● 3+ years of clinical trial and clinical trial source document creation experience● 2+ years of experience working within GCP, ICH, IP shipping (IATA, DOT, Dangerous Goods), and other regulations for pharmaceuticals
COVID-19 Vaccination Requirement
CVS Health requires its Colleagues in certain positions to be fully vaccinated against COVID-19 (including any booster shots if required), where allowable under the law, unless they are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents them from being vaccinated.
If you are vaccinated, you are required to have received at least one COVID-19 shot prior to your first day of employment and to provide proof of your vaccination status within the first 30 days of your employment. For the two COVID-19 shot regimen, you will be required to provide proof of your second COVID-19 shot within the first 60 days of your employment. Failure to provide timely proof of your COVID-19 vaccination status will result in the termination of your employment with CVS Health.
If you are unable to be fully vaccinated due to disability, medical condition, pregnancy, or religious belief, you will be required to apply for a reasonable accommodation within the first 30 days of your employment in order to remain employed with CVS Health. As a part of this process, you will be required to provide information or documentation about the reason you cannot be vaccinated. If your request for an accommodation is not approved, then your employment may be terminated.
Experience working at a clinical research site or site network
● Bachelor's degree in applied sciences, healthcare, business, or related field
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.
We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, ethnicity, sex/gender, sexual orientation, gender identity or expression, age, disability or protected veteran status or on any other basis or characteristic prohibited by applicable federal, state, or local law. We proudly support and encourage people with military experience (active, veterans, reservists and National Guard) as well as military spouses to apply for CVS Health job opportunities.
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