Job Description
Shape the Future of Medicine with Apex Therapeutics
We are a leading biotechnology firm dedicated to developing life-saving therapies. We are currently seeking a highly skilled Clinical Data Manager (CDMP) to join our dynamic team in Boston. In this role, you will be the guardian of data integrity, ensuring that clinical trial information is accurate, complete, and compliant with global regulations.
Why Join Us?
- Impactful Work: Play a direct role in bringing life-changing treatments to market.
- Modern Environment: Work with cutting-edge technology and a collaborative, cross-functional culture.
- Competitive Benefits: Comprehensive health, dental, and vision insurance, 401(k) matching, and continuous learning opportunities.
Responsibilities
- Design and execute comprehensive Data Management Plans (DMPs) in alignment with trial protocols.
- Oversee data validation and cleaning activities to ensure 100% accuracy and completeness of trial data.
- Maintain data integrity by performing regular audits and reconciling discrepancies with Clinical Operations.
- Manage the lifecycle of study data, from source document verification to database lock.
- Collaborate with Statistical Programming, Medical Writing, and Regulatory Affairs teams to ensure seamless data flow.
- Ensure strict adherence to Good Clinical Practice (GCP) and regulatory guidelines (FDA, EMA).
Qualifications
- Bachelor’s degree in Life Sciences, Statistics, Computer Science, or a related field; Master’s degree preferred.
- Minimum of 5 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Proficiency in CDISC standards (SDTM, CDASH) and data management tools (e.g., Rave, Oracle Clinical, REDCap).
- Strong analytical skills with the ability to troubleshoot complex data issues.
- Excellent communication skills and the ability to work effectively in a fast-paced, cross-functional environment.
- Experience with data query resolution and managing CROs is a plus.