Associate Director, Clinical Data Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide leadership, insights, and support for data management in both internal and external projects, as well as clinical trials.

• Act as the primary Clinical Data Manager for various clinical trials as necessary.

• Ensure that the data collected aligns with study objectives and adheres to company quality standards.

• Oversee data management staff and the activities of CROs/vendors.

• Guarantee that CROs comply with project timelines from the initiation of the study until its closure.

• Engage in cross-functional meetings to provide updates on project statuses, issues, and milestones.

• Analyze data using listings and visualization tools for performance and quality assessments.

• Conduct trend analyses both within and across studies.

• Lead interactions with third-party vendors concerning the collection, transmission, and transfer of study-specific data.

• Assist in the development and updating of SOPs to ensure regulatory compliance and meet operational needs.

• Travel is expected to be around 10%.

⛳️ Requirements

• A Bachelor's degree is a must.

• At least 6 years of experience in data management within the pharmaceutical, biotech, or CRO sectors.

• Extensive hands-on experience covering all facets of data management.

• A Bachelor's degree in Life Sciences, Mathematics, or health-related fields is preferred.

• Experience in the Oncology therapeutic area is desirable.

• Proven track record of managing CRO relationships and overseeing data management deliverables.

• Strong knowledge and practical experience with EDC systems, including Medidata RAVE or Veeva.

• Comprehensive understanding of GCP, CDISC/CDASH data structures, ICH guidelines, and FDA regulations.

• Exceptional verbal and written communication skills.

• Strong analytical and problem-solving skills.

• Capability to leverage AI for enhancing team execution and decision-making processes.

• Proficient in clinical systems such as EDC, IVRS, CTMS, eTMF, and other clinical project management tools.

• Ability to quickly learn new systems as required.

• Approximately 10% travel is required.

🏝️ Benefits

• Additional cash and stock incentive opportunities (subject to eligibility).

• Comprehensive medical, pharmacy, dental, and vision care.

• BMS Well-Being Account.

• BMS Living Life Better program.

• Employee Assistance Programs (EAP).

• 401(k) retirement plan.

• Short- and long-term disability insurance.

• Life insurance coverage.

• Accident insurance options.

• Supplemental health insurance available.

• Business travel protection.

• Personal liability protection provided.

• Identity theft benefits offered.

• Legal support services.

• Survivor support available.

• Flexible time off for US exempt employees, subject to manager approval.

• 11 paid national holidays.

• 160 hours of annual paid vacation for eligible new hires, with manager approval.

• 3 optional holidays.

• Unlimited paid sick time, depending on eligibility.

• Up to 2 paid volunteer days per year.

• Flexible summer hours, subject to eligibility.

• Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.

• Annual Global Shutdown between Christmas and New Year's Day, based on eligibility.