Assoc Manager, CDM Job at Bristol-Myers Squibb, Warsaw, KY

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  • Bristol-Myers Squibb
  • Warsaw, KY

Job Description

Position Summary The Associate Manager, Clinical Data Management is a Clinical Data Management team member role considered essential to complete end-to-end data management tasks on assigned studies across therapeutic areas. This role reports to a line manager within CDM and is a full-time office-based position with flexibility to work remotely up to 50% of the time over 2 weeks. Position Responsibilities 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 including EDC build kick‑off, Interactive eCRF Build, and IRMs for database and Edit checks. Create and finalize study documents such as Data Quality Management Plan, eCRF completion Instructions, Protocol Data Review Plan (PDRP). Ensure all startup documents are completed as per SOP and filed 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 execution of data review tasks. Coordinate with external data vendors for any escalations related to 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 conduct 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 ensure the 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. Ability to work on end-to-end Clinical Data Management tasks. Ability 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). Compensation Overview Warsaw - PL: zł194,000 - zł235,087 The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job such as required skills, location, work schedule, job‑related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws. Equal Employment Opportunity BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Accessibility and Accommodations BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. #J-18808-Ljbffr

Job Tags

Full time, Work at office, Remote work

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