Associate Director, Regional Clinical Compliance
Vor 2 Tagen
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.
The role of Associate Director, Regional Clinical Compliance is placed within the Global Clinical Compliance & Continuous Improvement (GCCCI) function of Global Development Operations (GDO) and reports to the Head of Regional Clinical Compliance Europe. This role will support and enable corporate GDO objectives through support of implementation of the GDO audit management plan, support country-level risk identification/management, preparing and providing local on-site local health authority inspection support assuring GDO is always inspection ready.
**Responsibilities**
- The role will be the primary contact for addressing local ICH GCP-related questions.
- The role supports assuring GDO is inspection-ready at all times.
- The role will interact with the Global Quality (GQ) function in support of any sponsor inspections and activities in any of the local markets. There will be a significant partnership with the GQ organization.
- This role will assure the development and implementation of compliance oversight visits and support the framework of the global clinical trial monitor/ CRA accompanied program.
- In partnership with the Regional Clinical Operations (RCO) and Global Quality Clinical Trial & Safety (CT&S) audit team, support the regional study teams and sites to assure inspection and audit readiness at all times.
- Support RCO in CAPA management process by driving Root Cause Analysis and CAPA development, follow-up of regional/site-level CAPA till closure.
- Inspection Support: Provide training for GDO inspection management. In collaboration with CT&S, coordinate site and sponsor inspections by Health Authorities depending on the Inspection type and conduct Pre-inspection visits as needed
- Support end-to-end clinical trial 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 the RCO team to share lessons learned, metrics discussion and quality culture integration, escalating trends and significant issues to governance levels
- Partnering with the GCCCI organization & RCO to identify gaps/needs in training at the regional, process improvements, and provide local training support/coordination as needed. Assurance that findings from the Accompanied Monitoring Program are tracked and acted upon as part of a wider QMS
- As the scope of GDO includes registrational and non-registrational data generation (NRDG), regional clinical compliance activities will span through Phase I through IV studies including Investigator-Sponsored Research and Real-World Data Generation. In that context, partner with GDO NRDG teams to enhance GCP compliance for NRDG in partnership with Regional/Country Medical.
- Work with RCO and GQ to foster a regional, cross-functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times.
- 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, BI&A (Business Insights & Analytics) and GDO to ensure compliance concerns are aligned across the region.
**Qualifications**:
- At least 5 years of experience in clinical trial operations and/or Good Clinical Practice is required.
- Strong knowledge of the global 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. 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 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 ove
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