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Job Details


Bristol Myers Squibb

Associate Director, Clinical Data Management

Management

Management

Yearly

No

Princeton, New Jersey, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

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. Takes responsibility for more complex studies in the portfolio which may require additional Clinical Data Management expertise
  • 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 data 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
  • Represents DM on cross-functional project teams, portfolio review meetings & Submission Teams
  • Lead or support the Health Authority inspections and audits
  • Maybe be assigned to a clinical program to provide program level oversight and governance for data management

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

  • 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
  • Mentor new or existing team members, as applicable
  • Holds accountability to resolve complex issues and proactively develop solutions, within the function and across functions. Leveraging technical/functional expertise to develop solutions. Using clear communications and collaborative strategies to drive to resolution.
  • Leads initiatives with broad, cross-functional impact (including strategic process and technology improvements), influencing direction and driving to completion.
  • Leads initiatives with broad, cross-functional impact (including strategic process and technology improvements), influencing direction and driving to completion.
  • Authors procedural documents (SOPs, work instructions, job aids) and coordinating reviews/approvals. Ensuring procedural documents are reflective of industry standards and regulatory requirements, include optimal processes and are regularly maintained.
  • Leads CAPA management activities, including root cause analysis and development of appropriate actions to address the root cause. Ensuring timely closure of CAPA actions.
  • Developing strong and productive working relationships with key stakeholders throughout GDM&CM, GDO, and BMS to drive results and remove barriers to execution.

Line Management

  • Maybe to responsible for line management of Data Management Leads based on business requirements and
  • Manages the resource assignments ensuring appropriate support is in place to provide data quality oversight for clinical trials
  • Forecast’s future resource needs based on the book of work and initiatives; proposing solutions to meet potential resource constraints
  • Assigns resources to initiatives in line with their development plans and providing appropriate guidance to staff to influence results and drive to completion
  • Works proactively with staff to understand individual strengths, opportunities, and career goals; supporting development of plans that capitalize on strengths and address opportunities; providing regular feedback to promote development.
  • Effectively coaches and mentors’ staff, seeking out training opportunities where needed, to develop the next generation leaders.
  • Develops and promotes a workplace culture that values diversity of thought, promotes integrity, creates accountability, supports effective decision making, and provides opportunities to grow.

Clinical Data Management Leadership team member

The resource may serve as a Clinical Data Management Leadership team member responsible to contribute the overall Clinical Data Management leadership objectives and below are some examples of the activities around the responsibilities:

  • Acts in a leadership capacity for procedural documents and ensuring documents are reflective of industry standards/regulatory requirements and optimal processes. Includes authoring procedural documents, working on document integration efforts, coordinating reviews/approvals, maintaining documents, and coordinating connection points across stakeholder groups. May also assign and coordinate activities with other Therapeutic Area Leaders.
  • Provides operational leadership within Clinical Data Management to enable continuous improvement
  • Manages trackers, metrics, and key performance indicators for the function and coordinates with Therapeutic Area Heads to address trends
  • Coordinates timely closure of CAPA actions in partnership with the CDM leadership team
  • Facilitates and provide regular reports on defined health metrics to CDM leadership across all Therapeutic areas
  • Develops strong and productive working relationships with key stakeholders throughout GDM&CM, GDO, and BMS with the ability to think strategically and to communicate with and influence senior management.
  • Coordination of resource management activities across all Therapeutic areas within Clinical Data Management and help the leadership team understand resource capacity across all Therapeutic areas
  • Representing BMS in interactions with key external partners as part of any committee or industry group relating to the function

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.

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

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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.