Associate Manager, Clinical Data Management.

Responsibilitiesl

Responsibilities will include, but are not limited tol

- 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.

- 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.

- Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed).

- If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.

- You could be one step away from work that will transform your life and career.

- Uniquely Interesting Work, Life-changing Careers.

- With a single vision as inspiring as Transforming patients' lives through science- , every BMS employee plays an integral role in work that goes far beyond ordinary.

- Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.