Associate Director, Clinical Data Management
About The Position
The Associate Director, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role 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. The position efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects. The Associate Director is responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members. They may act as a driver to set program-level data collection and review standards with cross-functional teams in partnership with global standards. This role provides strong quality and project oversight over third-party vendors responsible for data management deliverables and takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). The Associate Director enforces data standard conventions and quality expectations for clinical data per defined processes, authors, reviews/revises DM-related 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. They chair Data Quality Review meetings with cross-functional study team members to ensure ongoing review of trial data currency, quality, and completeness, and represent DM on cross-functional project teams & submission teams. The role also involves leading or supporting Health Authority inspections, audits, and CAPA implementation, providing coaching and quality oversight of junior Data Management Leads, and leading or co-chairing department Data Management Lead forums. Additionally, the Associate Director 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 monitor DM deliverables according to the Service Level Agreement (SLA). They may also act as a functional representative and a point of contact for CRO and preferred vendors. In terms of continuous improvement, the Associate Director supports change management initiatives with broad impact as a lead or participant and/or authors (or participates in) functional SOPs/WP/GD. They utilize knowledge of data management processes to evaluate and recommend new technologies and systems for improved data management functionality.
Requirements
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
- Sound knowledge of 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
- Communicate 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)]
- Bachelor’s Degree in life sciences, data science, statistics is required
- 7+ years of experience in Biopharma/CRO
- 3+ years in study/program leadership role
Nice To Haves
- advanced degree preferred
Responsibilities
- 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 and reliable clinical trial data in a timely manner for assigned projects
- Responsible for end to end clinical data management activities and serves as a 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 team 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 close collaboration 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/revises DM related 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 on-going review of trial data currency , quality and completeness
- Represents DM on cross-functional project teams & submission Teams
- Lead or support the Health Authority inspections, audits, and CAPA implementation
- Provides coaching and quality oversight of junior Data Management Leads
- Lead or co-chair the department Data Management Lead forums
- May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
- May act as a functional representative and a point of contact for CRO and preferred vendors
- Supports change management initiatives with broad impact as a lead or participant in initiatives, and/or authors (or participates in) functional SOPs/WP/GD
- Utilizes knowledge of data management processes to evaluate and recommend new technologies and systems for improved data management functionality
Benefits
- Medical, pharmacy, dental, and vision care
- BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
- 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
- flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
- 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
- unlimited paid sick time
- up to 2 paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- an annual Global Shutdown between Christmas and New Years Day
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
