Associate Manager, Clinical Data Management

Associate Manager, Clinical Data Management

BMS - Bristol-Myers Squibb

Warsaw, Poland

Position Summary

The Associate Manager, Clinical Data Management is a Clinical Data Management team member role considered essential to complete end to end to data management tasks on assigned studies across therapeutic areas. This role will report into a line manager within CDM. It is a full-time 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:

Study Startup:

• Draft EDC build timeline in collaboration with Data Management Lead;
• Perform DB build tasks by creating specifications for Database and Edit Checks;
• Create test scripts and complete test data entry/UAT for Coding, Site Payment, Safety Gateway;
• Collaborate with Data Management Lead and facilitate startup meetings which includes, not limited to, EDC build kick-off, Interactive eCRF Build and IRMs (Interactive Review Meeting) for database and Edit checks;
• Create and finalize study documents like Data Quality Management Plan, eCRF completion Instructions, Protocol Data Review Plan (PDRP) post study team review;
• Ensure all startup documents are completed as per SOP and filled in eTMF as per eTMF master plan.

Study Conduct:

• Plan/execute Post Production/Migration for the study (if any);
• Coordinate with Clinical Data Managers for the execution of data review tasks;
• Coordidate with external data vendors for any escalations related to any vendor data;
• Support Clean Patient Group delivery along with Clinical Data Management staff;
• Update study documents as needed during the conduct of the study;
• Support DML to coduct Data Quality Review meetings;
• Provide Data Health Metrics to Data Management Lead as requested.

Study Closeout:

• Support Data Management Lead in planning and execution of database lock activities;
• Perform post lock activities, as needed.

Project Management:

• Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality.

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;
• 6 years of experience in managing end to end Clinical Data Management tasks;
• Able to work on end to end Clinical Data Management 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;
• Strong project management skills;
• Travel Required Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed).