Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
This role will report to the Head of Regional Clinical Compliance who is a member of the Global Clinical Compliance & Continuous Improvement (GCC&CI) leadership team under Global Clinical Operations (GCO). Responsibilities will include:
- In partnership with the Regional Clinical Operations and Global Quality CT&S (Clinical Trial & Safety), support the regional study teams and sites to assure inspection and audit readiness at all times.
- Support RCO in CAPA management process:
- Drive Root Cause Analysis and CAPA development
- Follow up of regional/site-level CAPA till closure
- Inspection Support: Training for inspection management.
- In collaboration with CT&S, coordinate site and sponsor inspections by Health Authorities depending on the Inspection type
- Conduct Pre-inspection visits as needed
- Support end-to-end risk management process at site, country and regional level throughout the study.
- Provide oversight of compliance issue management and act as primary contact for GCP & regulatory compliance questions
- Lead Hub/Country compliance forum in partnership with clinical operation team to share lessons learnt, metrics discussion and quality culture integration, escalating trends and significant issues to governance levels
- Partnering with the GCC&CI CI organization & Regional Clinical Operation to identify gaps/needs in training at the regional level, and providing local training support/coordination as needed.
- As the scope of Global Clinical Operations includes registrational and non registrational data generation (NRDG), regional clinical compliance activities will span across Phase I through IV studies including Investigator-Sponsored Research and Real World Data Generation. In that context, partner with GCO NRDG teams to enhance GCP compliance for NRDG in partnership with Regional/Country Medical.
- Work with regional clinical operations and Global Quality to foster a regional, cross- functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times.
- Conduct compliance oversight visits.
- Perform Vendor oversight aligned with regional clinical operation’s expectations, as needed.
- Oversight of local procedural documents and provide training on new revised GCP compliance related SOPs/regulations as needed
- Working with other stakeholders such as Medical, Legal or Regulatory, Safety, BIA (Business Insights & Analytics) and Development to ensure compliance concerns are aligned across the region
•A minimum of a Bachelor's Degree or equivalent is required. A degree in Life Sciences or equivalent is preferred. At least 5 years of experience in clinical trial operations and/or Good Clinical Practice is required. Fluency in a second language relevant to the geographical scope is a plus.
•Good 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 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 with a cross-functional team.
•Ability to manage multiple projects simultaneously to ensure timely, execution of tasks. Attention to detail with excellent planning, time management and organizational skills.
•Ability of comforting on issue escalation
•Have a strategic mindset to translate local needs into effective regional country compliance oversight plans
•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.
This role will require domestic and international travel up to 30%
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.