Associate Director, Clinical Data Management

About this role

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Position Summary 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

Responsibilities will include, but are not limited to: 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 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

  FSP/CRO/Vendor Oversight • 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

Continuous improvement initiatives • 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

  Competency 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)]

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

• Travel: 5-10% Industry Conferences, Internal and Investigator Meetings, Regulatory Inspections (as needed)

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Madison - Giralda - NJ - US: $170,800 - $206,968
 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. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.   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.

• Well

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