Job Title: Associate Director, Clinical Data Management
Location: Otemachi, Japan
Department: Clinical Data Management
Reports To: Director, Clinical Data Management (or equivalent)
Job Summary
The Associate Director, Clinical Data Management is a leadership role responsible for overseeing data management activities for complex clinical development projects. The role ensures high-quality, reliable clinical trial data, provides strategic oversight of third-party vendors, and contributes to continuous process improvements.
Key Responsibilities
1. Project Management & Leadership
Lead clinical data management activities for one or more complex clinical development projects.
Ensure timely, high-quality, and complete clinical trial data delivery.
Act as the primary contact for internal and external study team members.
Set program-level data collection and review standards in partnership with global standards teams.
Oversee third-party vendors for data management deliverables.
Collaborate on Electronic Data Capture (EDC) system integration (e.g., eCOA, External Data, Safety Gateway).
Develop and maintain study-related data management plans (e.g., Data Quality Management Plan, Validation Plans).
Chair Data Quality Review meetings to monitor trial data quality and completeness.
Represent Clinical Data Management (DM) on cross-functional project and submission teams.
Support regulatory inspections, audits, and CAPA implementation.
Provide coaching and oversight to junior Data Management Leads.
Lead or co-chair Data Management Lead forums within the department.
2. FSP/CRO/Vendor Oversight
Serve as a core study team member, overseeing Functional Service Provider (FSP)/CRO/vendor data management activities.
Monitor data currency, adherence to SLAs, and overall study deliverables.
Act as the primary functional representative and point of contact for CROs and preferred vendors.
3. Continuous Improvement Initiatives
Lead or participate in change management initiatives that impact data management practices.
Develop, revise, or contribute to Standard Operating Procedures (SOPs), Work Processes (WPs), and Guidelines (GDs).
Assess and recommend new technologies and systems for improved data management functionality.
Qualifications & Experience
Education:
Bachelor’s Degree in a relevant scientific or healthcare field (advanced degree preferred).
Experience:
5+ years of industry experience in clinical data management.
Experience working in clinical drug development, with knowledge of FDA/ICH guidelines and data management best practices.
Prior experience with EDC systems (Medidata RAVE preferred).
Experience managing cross-functional teams and external vendors.
Project Management certification (e.g., PMP) is desirable.
Technical & Soft Skills:
Strong project management and leadership skills.
Proficiency in MS Office Suite and familiarity with emerging technologies in data collection.
Ability to analyze and interpret clinical trial data and metrics.
Strong oral, written, and interpersonal communication skills.
Ability to work effectively with senior management, cross-functional teams, and external vendors.
Knowledge of regulatory submission requirements (NDA, BLA, MAA).
Compensation & Benefits
Competitive salary & incentives (details based on eligibility).
Comprehensive benefits package including healthcare, retirement plans, and work-life balance programs.
Opportunities for career growth and development within BMS.
Work Environment & Travel
Hybrid work model with flexibility.
Occasional travel (5-10%) for industry conferences, investigator meetings, and regulatory inspections.
Why Join Bristol Myers Squibb?
At BMS, we are driven by our mission to transform patients’ lives through science. This role offers a unique opportunity to contribute to life-changing innovations in a dynamic, inclusive, and collaborative environment.
Apply today and be a part of something bigger!
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