Associate Director, Clinical Data Management
About the role
The Associate Director, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. Key responsibilities include project management and leadership, efficient planning and delivery of clinical trial data, and continuous improvement initiatives.
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
- Acts as a driver to set program level data collection and review standards with cross functional team in partnership with global standards
- 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
- 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
- Represents DM on cross-functional project teams & submission teams
- Leads or supports the Health Authority inspections, audits, and CAPA implementation
- Takes a coaching and quality oversight role over junior Data Management Leads
- Lead or co-chair the department Data Management Lead forums FSP/CRO/Vendor Oversight
- 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)
- Supports change management initiatives with broad impact as a lead or participant in initiatives, and/or authors (or participates in) functional SOPs/WP/GD
- Uses knowledge of data management processes to evaluate and recommend new technologies and systems for improved data management functionality
Qualifications & Experience
- Bachelor’s Degree in life sciences, data science, statistics is required with an advanced degree preferred
- 7+ years of experience in Biopharma/CRO with 3+ years in study/program leadership role
Compensation Overview
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience.
Benefits
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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
- Paid Time Off
- 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
- Annual Global Shutdown between Christmas and New Years Day