Sr. Clinical Data Manager

Sr. Clinical Data Manager

BMS - Bristol-Myers Squibb

Warsaw, Poland

Position Responsibilities

Responsibilities will include, but are not limited to:

Data Review:

• Understand and review Protocol along with relevant study specific data review documents.
• Provide input to data review documents like Protocol Data Review Plan, Data Quality Management Plan.
• Review clinical data listings and prioritize critical data review.
• Manage and facilitate resolution of data discrepancies.
• Perform data cleaning as per the defined Clean Patient Group.
• Freezing & Locking of CRFs/Fields.
• Coordinate with Data Management Lead for study deliverables.

External Data:

• Track data load and address discrepancies.
• Complete review of loaded external data and prioritize complex external data review e.g. Blinded Independent Committee Review, Biomarker, SAE.
• Coordinate with external data vendor for resolution of data discrepancies as applicable.

Documentation:

• Filing of appropriate documents in eTMF as per eTMF master plan.

Training and Mentorship:

• Provide Training and mentoring to junior CDM staff.

Requirements

• Bachelor’s Degree required. Life sciences, Pharmacy or relevant fields preferred.
• 4 years of experience in Clinical Data Review tasks.
• Able to work on clinical data review tasks.
• Able to work collaboratively on multi-disciplinary project teams.
• Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines
• and industry standard practices regarding data management.
• Strong knowledge and experience of EDC systems (Medidata RAVE preferred).
• demonstrated knowledge of Microsoft Office skills.
• Strong oral and written communication skills.