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Associate Director, Clinical Data Management

$170.8k - $206.97k

Bristol Myers Squibb EU Policy

Challenging. Meaningful. Life‑changing. Working at Bristol Myers Squibb transforms both patient lives and the careers of those who do it. Position Summary Associate Director of Clinical Data Management is a leadership role essential to the sustainability and success of the BMS R&D pipeline. Key Responsibilities Project Management and Leadership Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects. Efficiently plans, coordinates, and delivers complete, high‑quality, reliable clinical trial data in a timely manner for assigned projects. Is responsible for end‑to‑end clinical data management activities and serves as the primary point of contact for internal and external study team members. May act as a driver to set program‑level data collection and review standards with cross‑functional teams in partnership with global standards. Provides strong quality and project oversight over third‑party vendor responsible for data management deliverables. Takes a leadership role to gather content and integration requirements for EDC and collaborates closely with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes. Authors, reviews, and revises data‑management study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization. Chairs data quality review meetings with cross‑functional study team members to ensure ongoing review of trial data currency, quality and completeness. Represents data management on cross‑functional project teams and submission teams. Leads or supports health authority inspections, audits, and CAPA implementation. Provides coaching and quality oversight of junior data‑management leads. Leads or co‑chairs the departmental data‑management lead forums. FSP/CRO/Vendor Oversight May act as a core member of the study team and provide FSP/CRO/Vendor oversight for end‑to‑end data management activities, manage data currency throughout the trial, and overall monitor data management deliverables according to the service level agreement (SLA). May act as a functional representative and a point of contact for CRO and preferred vendors. Continuous Improvement Initiatives Supports change‑management initiatives with broad impact as a lead or participant, and/or authors (or participates in) functional SOPs, work papers, and guidance. Utilizes knowledge of data management processes to evaluate and recommend new technologies and systems for improved data‑management functionality. Competency Requirements Able to work collaboratively on multi‑disciplinary project teams and develop productive relationships with external vendors. Sound knowledge of the 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 and well versed in industry trends and emerging technologies supporting data collection. Strong project management; exhibits expertise in metrics analysis and reporting methodologies. Excellent oral and written communication skills. Communicates effectively with senior management and cross‑functional teams. Knowledge of submission requirements (e.g., New Drug Application (NDA), Biologics License Application (BLA), Market Authorization Application (MAA)). Qualifications & Experience Bachelor’s Degree in life sciences, data science, or statistics is required; an advanced degree is preferred. 7+ years of experience in biopharma/CRO with 3+ years in a study/program leadership role. Travel: 5–10% for industry conferences, internal and investigator meetings, regulatory inspections (as needed). Compensation and Benefits Madison – Giralda – NJ – US: $170,800 – $206,968 per year. Additional incentive cash and stock opportunities (based on eligibility) may be available. Benefit Offerings: Health Coverage: Medical, pharmacy, dental, and vision care. Well‑being Support: 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. Paid Time Off: Flexible time off (unlimited, with manager approval) and 11 paid national holidays for US exempt employees. Phoenix, AZ, Puerto Rico, and Rayzebio employees receive 160 hours annual paid vacation for new hires, 11 national holidays, and 3 optional holidays. Additional benefits may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence, and an annual Global Shutdown between Christmas and New Year's Day. Candidate Rights BMS will consider qualified applicants with arrest and conviction records in accordance with applicable laws. #J-18808-Ljbffr

Vacancy posted 5 hours ago
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