Risk Management Lead
About Bristol-Myers Squibb:
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
This role will report to the Director of Quality Clinical Compliance and Risk Management who is a member of the Global Clinical Compliance & Continuous Improvement (GCC&CI) leadership team under Global Clinical Operations (GCO). Each Risk Management Lead will be assigned a certain part of the Bristol-Myers Squibb clinical trial portfolio and will work conjunctly with their peers to ensure consistency across the function. Responsibilities will include:
- Collaborate with the study teams and help build Quality by Design from protocol development and study startup, to database lock, and through protocol amendments, to ensure appropriate cross-functional coordination of risk assessment and management throughout the duration of Clinical Trials. Own the Risk Assessment and Categorization Tool (RACT) and work closely with all functions involved to assure alignment on the Quality Threshold Limits (QTLs) and the Risk-Based approach to monitoring with proper documentation of actions and accountabilities.
- During the identification of potential clinical operations external partners (Contract Research Organizations, specialty labs, etc), work on the technical assessment as part of the due diligence process, to determine Quality and Compliance capabilities and health of the Quality Management System of the potential partner. Work closely with the Clinical Trial Planning and Alliance Management team as well as the Global Quality organization to develop appropriate Quality Agreements and Quality Oversight management plans with partners. Provide day-to-day vendor oversight and ensure appropriate documentation of such.
- Perform ongoing assessment of the effectiveness of the Risk Mitigation activities identified in the RACT and escalate to the right level of Governance as needed.
- Collaborate with Regional Clinical Compliance teams to support Global Clinical Operations study teams to be inspection ready at all times. Coordinate Inspection Preparedness efforts and support sponsor audits and inspections in partnership with Global Quality.
- Serve as Corrective Action Preventive Action (CAPA) lead and support individual CAPA owners to conduct root cause analyses, develop mitigation plans, and implement CAPAs within prescribed deadlines.
- Advise the Clinical Training, Process and Continuous Improvement team as to training needs and provide input into Quality Improvement Plans.
- Work with management and Global Quality to foster a cross functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset.
- A minimum of a Bachelor's Degree or equivalent is required. A degree in Life Sciences or equivalent is preferred. At least 5 years in the pharmaceutical industry and 2 years of experience in clinical trial operations and/or Good Clinical Practice is required.
- Robust understanding of the drug development process and clinical operations, experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions.
- Experience with the RACT and Risk-Based Monitoring principles, experience with eTMF, Veeva systems, CTMS (Seibel) and other quality systems is required.
- Experience in matrix management and training is desirable with the ability to engage and inspire others. Good communication skills with a proven ability to effectively engage and manage key internal stakeholders (in various functions and geographies) as well as external stakeholders (including Health Authorities). Good presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner.
- Experience in Project Management is a plus in the context of Inspection Preparedness.
- Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills.
- The candidate will demonstrate the ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with speed, accountability and integrity, and to have fun along the way.