Associate Manager, Clinical Data Management
2 weeks ago
Description
CDM is responsible for ensuring the integrity, reliability, completeness, and quality of clinical trial data and provides leadership in clinical data management for trials within the BMS R&D portfolio.
Position Overview
The Senior Clinical Data Manager plays a crucial role in completing data review tasks for assigned studies across different therapeutic areas, reporting to a line manager in CDM. This is a full-time position based in the office, allowing for up to 50% remote work flexibility over 2 weeks.
Key Responsibilities include:
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
- Facilitate startup meetings in collaboration with Data Management Lead
- Create and finalize study documents
- Ensure completion of startup documents as per SOP
Study Conduct:
- Plan/execute Post Production/Migration for the study
- Coordinate data review tasks with Clinical Data Managers
- Work with external data vendors when necessary
- Support Clean Patient Group delivery
- Update study documents during the study conduct
- Support Data Management Lead in Data Quality Review meetings
- Provide Data Health Metrics to Data Management Lead
Study Closeout:
- Support Data Management Lead in planning and executing database lock activities
- Perform post lock activities as required
Project Management:
- Assist in project management tasks to ensure successful study delivery
Documentation:
- Ensure proper filing of documents in eTMF
Training and Mentorship:
- Provide training and mentorship to junior CDM staff
Degree Requirements:
Bachelor's degree in Life Sciences, Pharmacy, or related fields is required.
Experience Requirements:
Minimum 6 years of experience in end-to-end Clinical Data Management tasks.
Key Competency Requirements:
- Able to work on end-to-end Clinical Data Management tasks
- Strong knowledge of FDA/ICH guidelines and data management practices
- Experience with EDC systems (Medidata RAVE preferred) and Microsoft Office
- Excellent communication and project management skills
Travel Required:
Occasional travel to Industry Conferences, Investigator Meetings, and Regulatory Inspections as needed.
Work Environment:
No exposure to disagreeable conditions in the work environment.
Career Development:
Join a team with a strong mission of transforming patients' lives through science, where each employee is valued for their unique contributions and perspectives.
On-site Protocol:
BMS offers diverse occupancy structures guiding work requirements. On-site presence is essential for collaboration and innovation, with various roles allowing for hybrid or remote work based on job responsibilities.
Vaccination and Equal Opportunity:
BMS emphasizes the importance of well-being, recommending full Covid-19 vaccination for all employees. The company values equality, providing transparent recruitment and support for individuals with disabilities, alongside equal employment opportunities.
Legal Compliance:
BMS complies with applicable laws regarding applicants with arrest or conviction records and ensures data privacy in all recruitment processes.
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