Senior Manager, Regional Clinical Compliance

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 Regional Clinical Compliance Lead is placed within the Global Clinical Compliance & Continuous Improvement function of Global Clinical Operations (GCO) and reports to the Head of Regional Clinical Compliance (Asia Pacific). This role will support and enable corporate GCO objectives through support of implementation of the GCO Audit Management Plan, support country-level Risk Identification/Management, preparing and providing local on-site local Health Authority Inspection support assuring GCO is inspection ready at all times. The role is the primary point of contact to address local ICH GCP related questions. The role will work in significant partnership with the Global Quality organisation in support of any sponsor inspections and activities in the local market. Responsibilities 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 by driving Root Cause Analysis and CAPA development, follow-up of regional/site-level CAPA till closure. Inspection Support: Provide Training for GCO 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 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, process improvements, and providing 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 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. Qualifications, experience and competencies Our ideal candidate will have in-depth knowledge of CRA operations with a passion for quality & A minimum of a Bachelor's Degree (or equivalent degree) is required. Degree in a life science or equivalent is preferred. 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 and 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 to drive and manage issue escalation. Have a strategic mindset to translate local needs into effective regional country compliance oversight plans. The successful 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. To protect the safety of our employees, third parties, customers, patients and communities, BMS Australia requires all employees to be fully vaccinated using a locally approved vaccination against COVID-19, unless an exemption is applicable under the State or Federal legislation relevant to you (e.g. your state’s anti-discrimination act). Within our policy an exemption can only be approved by the HR Director. By applying for this role, you understand that you will be asked if you can comply with the Policy
LI-Onsite 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.