Senior Manager, Clinical Data Management

Full Time
San Diego, CA
Posted
Job description

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 rich in diversity. 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.

The Senior Manager, Clinical Data Management (Data Management Lead) is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Director, Clinical Data Management or Associate Director, Clinical Data Management (Line Manager) within the Global Data Management and Centralized Monitoring function of Global Development Operations (GDO).

This is an office-based position across multiple BMS offices at Princeton/Lawrenceville NJ, Berkeley Heights NJ, & Boudry, Switzerland.

This strategic role is responsible for:

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

    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 and audits

    Provides coaching and quality oversight of junior Data Management Leads

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)

Continuous improvement initiatives

  • Lead/provide the relevant support and input to continuous improvement activities within clinical data management

    Provides support for CAPA implementation as required

Experience and Expertise Required

  • Bachelor’s degree required with an advanced degree preferred.

    At least 5 years of relevant industry experience.

    Project management certification (e.g. PMP) is desirable.

    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)]

Travel Requirements

  • 5-10%

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

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.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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