Provide data management leadership, insight, and support to all internal and external projects and clinical trials.
May simultaneously function as lead Clinical Data Manager for multiple clinical trials.
Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
Manage and provide oversight of data management personnel and activities of CROs and vendors.
Ensure CRO adherence to project timelines, from study startup to study closeout, while maintaining high quality and integrity of deliverables.
Engage in cross-functional meetings, providing updates on project status, issues, and milestones.
Review data using listings and visualization tools for performance and quality reporting, conducting reviews within studies and across multiple studies for trend analysis.
Lead interactions with third party vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data.
Proficient in clinical systems including EDC, IVRS, CTMS, eTMF, and other clinical project management tools; ability to learn new systems as needed.
Contribute to SOP development and updates to meet regulatory compliance and operational needs.

Requirements

Bachelor’s degree in Life Science, mathematics, or health-related fields preferred.
Minimum of 6 years data management experience in pharmaceutical/biotech/CRO industry; extensive hands-on experience in all aspects of data management.
Experience in the Oncology therapeutic area is preferred.
Proven ability to manage CRO relationships and oversee data management deliverables.
Strong knowledge and experience of EDC systems (Medidata RAVE preferred).
Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines and FDA regulations.
Excellent verbal and written communication skills.
Strong analytical and problem-solving abilities.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays).
Flexible vacation time with manager approval, 11 national holidays, and additional time off for medical, personal, parental, caregiver, bereavement, and military needs.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data managementclinical data managementdata analysistrend analysisregulatory complianceSOP developmentGCPCDISCCDASHFDA regulations

Soft Skills

leadershipcommunicationanalytical skillsproblem-solvingcross-functional collaboration