Lead Clinical Data Management Specialist
7 days ago
Unlock a rewarding career in clinical data management with Lifelancer, the leading talent-hiring platform in Life Sciences, Pharma and IT. We are seeking a highly skilled Senior Clinical Data Manager to join our team.
About the Role:
We are looking for a seasoned professional with at least 5 years of experience in pharmaceutical clinical trial data management or equivalent experience as a Clinical Data Manager II. The ideal candidate will have a strong leadership background, excellent communication skills, and the ability to work independently with minimal supervision.
Responsibilities:
- Design and review case report forms (CRFs/eCRFs), develop and review Case Report Form Completion Instructions, generate and review annotated Case Report Forms
- Participate in database design process, participate in Electronic Data Capture (EDC) User Acceptance Testing (UAT)
- Develop and maintain data validation specifications, develop and maintain Data Management Plan (DMP), document deviations from the DMP
- Manage database modifications after go-live due to protocol amendments or study needs, develop and maintain Data Quality Review Plan (DQRP), coordinate with programmers to complete programming and validation of listings and summary tables
- Perform Third Party non-CRF data management activities, review data, issue and resolve queries, assist Investigative Site personnel with resolving queries
- Perform Serious Adverse Event reconciliation, assist in resolving medical coding discrepancies, cooperate and assist Quality Assurance Department with quality control audits on assigned databases
- Maintain and prepare final archival of data management documentation relevant to assigned clinical trials
Qualifications and Experience:
- Bachelor's or Master's degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields
- Demonstrated an in-depth understanding of clinical trial data management concepts, processes, and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions, and standards
What You'll Get:
A competitive salary of $90,000 - $110,000 per year, depending on experience, plus a range of benefits including comprehensive health insurance, retirement plan, paid time off, and opportunities for professional growth and development.
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