Clinical Data Manager

Clinical Data Manager

BMS - Bristol-Myers Squibb

Warsaw, Poland

Position Summary

The Clinical Data Manager is a Clinical Data Management team member role considered essential to complete data review tasks on assigned studies across therapeutic areas. This role will report into a line manager within CDM. It is a fulltime office-based position with flexibility to work remotely up to 50% of the time over 2 weeks.

Position Responsibilities

Responsibilities will include, but are not limited to:

Data Review:

• Understand and review Protocol along with relevant data review documents (e.g. Protocol Data Review Plan, Data Quality Management Plan);
• Review clinical data listings;
• 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:

• Complete review of loaded external data;
• Track data load and address discrepancies;
• Coordinate with external data vendor for resolution of data discrepancies as applicable.

Documentation:

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

Requirements

• Bachelor’s Degree required. Life sciences, Pharmacy or relevant fields preferred;
• 2 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;
• Basic knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management;
• Good knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills;
• Good oral and written communication skills.