Shanghai Head Of Clinical Operations, ExpMED China Chin

Job description

Head of ClinOps(Double Hatted CTM Country Lead),China The purpose of the position : 1)To steer Clinical Operations pre-poc with the target to optimally address speed, quality and efficiency of preparation, conduct, analyzing and reporting of Clinical Trials and Development Programs within the definitions set by legal and regulatory boundaries as well as scientific and ethical standards. 2)Provides strategic leadership and operational oversight at the Regional/Operative Unit (R/OPU) level to ensure the successful planning, execution, and reporting of high-quality pre-PoC clinical trials in alignment with corporate and functional objectives. This role is pivotal in building and managing a high-performing team of Clinical Trial Managers (CTMs) or Regional CTMs (RCTMs), fostering a culture of excellence and accountability, grounded in science. 3) Serves a the regional liaison for assigned countries and regions, ensuring oversight of clinical trial delivery and acting as the primary point-of-contact for Clinical Operations topics. Collaborates with global teams to share best practices, resolve challenges, and lead or participate in strategic initiatives. Key responsibilities include: * Overseeing trial delivery and CTM performance, ensuring adherence to timelines, budgets, recruitment goals, and regulatory, legal, ethical, and quality standards while safeguarding patient safety and data integrity. * Serving as the primary point of contact for clinical operations topics within assigned countries/regions and liaising with internal stakeholders such as Clinical Development Operations, Medical Affairs, and Quality Medicine. * Managing resource allocation, personnel development, and performance management, including compliance with SOPs, process documents, and training curricula. * Supporting the Global Head of Clinical Trial Management with budget oversight, strategic initiatives, and issue resolution. * Driving process optimization, operational excellence, and cross-functional collaboration to meet pipeline commitments and enhance study management capabilities. * Serving as the liaison for assigned countries to coordinate clinical trial resourcing and delivery. * Where required, act as administrative line manager to ExpMED personnel within country. The Team Lead ensures consistent communication with stakeholders, provides trial updates, and escalates operational issues as needed. This role is critical in promoting efficiency, quality, and patient-centricity across all R/OPU pre-PoC clinical trial activities. 1. Team Leadership and Delivery of Pipeline Commitments Provide strategic leadership and operational oversight at the R/OPU level to ensure excellence in planning, design, quality, and execution of pre-PoC clinical trials, delivering the R/OPU contribution and meeting pipeline commitments aligned with ExpMED priorities. Ensure R/CTMs understand their accountabilities, responsibilities, and deliverables, including optimal planning, resourcing, and trial execution. Oversee trial management from start-up to closure, ensuring quality, timelines, recruitment, cost control, and resource utilization. Lead strategy for inspection readiness and sponsor oversight, and support CTMs in timely resolution of trial-related issues, including monitoring oversight and open deviations. Promote best practices by leveraging data, technology, and patient-centric approaches to maximize value for sites and participants. Critically evaluate data for accuracy and completeness in key deliverables (e.g., trial reviews, budgets) and make objective, data-driven decisions. Act as a role model by integrating Our Behaviors into daily leadership, fostering a high-performing team culture, and proposing solutions to operational challenges with clear risk analysis. 2. Talent Management and Workforce Development Build and sustain a high-performing Clinical Ops workforce through effective recruitment, onboarding, development, and retention strategies in close collaboration with the Global Provide strong team leadership by setting clear expectations, fostering accountability, and creating an empowering environment that motivates colleagues and promotes a cohesive Experimental Medicine identity. Lead performance management activities, including MAG reviews, development planning, and timely feedback, while identifying performance challenges and implementing action plans. Cultivate a performance-driven culture with a sense of urgency for achieving results, ensuring staff are coached and developed in department-specific knowledge, processes, and procedures. 3. Compliance and Quality Assurance: · Ensure adherence to national and international regulatory and legal requirements, as well as internal SOPs and guidelines. · Cross functional cooperation within and across departments for: * Audits (internal and external) • Inspections (Sponsor/ site) * Support the CAPA process and timely issue resolution. · Provide leadership and guidance to ensure R/CTM oversight of clinical trial activities is enhanced. * Provide proactive solutions to issues arising in clinical trials. 4. Cross-Functional Collaboration Develop and maintain strong relationships with internal and external stakeholders to ensure effective cross-functional collaboration and alignment at local, regional, and global levels. Internal stakeholders include R/OPU Medical Affairs, Planning Hub, Clinical Development Operations functions, and Quality Medicine. External stakeholders may include investigators and patient advocacy organizations. Represent ExpMED Clinical Operations in interdisciplinary projects, working groups, and joint initiatives to enhance clinical trial strategies, integrate trial management topics, and support business objectives. Actively contribute to stakeholder alignment and participate in relevant congresses to foster collaboration and knowledge sharing across ExpMED. 5. Strategic Collaboration and Operational Planning Actively participate in global and local therapeutic area (TA) meetings, Clinical Operations trial reviews, and other strategic discussions as the Clinical Operations representative on relevant project teams. Provide operational feedback on proposed study designs and endpoints, and facilitate input from country experts to optimize trial feasibility and execution. Support global TA teams in identifying innovations and synergies to enhance clinical development programs, while assisting country/region teams with the implementation of new systems and processes. Proactively plan and prepare for the successful conduct of trials of strategic importance to the company and/or region, ensuring alignment with organizational priorities. 6. Resource Management and Allocation Coordinate and manage resources across therapeutic areas and the R/OPU portfolio to ensure optimal trial delivery. Oversee CTM resourcing, capacity planning, and trial allocation in collaboration with the global ExpMed Clinical Operations team. Manage recruitment and onboarding of qualified R/OPU CTMs and external CRO RCTMs as applicable to maintain appropriate resource levels, expertise, and team dynamics. Support the Global Head, CTM in resource planning and allocation across the entire portfolio to achieve operational efficiency and meet pipeline commitments. 7. Regional Liaison and Coordination Liaison for assigned countries conducting ExpMED clinical trials. Ensure resourcing and coordinate oversight of trial delivery within assigned regions and primary point-of-contact for Clinical Operations topics of relevance across the region. Collaboration with global teams to share best practices, resolve challenges, lead / participate in initiatives. 8. Support the Global Head, Clinical Trial Management, in implementing a customer-focused culture within ExpMED by promoting a commitment to customer-centric behaviors: * provides visibility to trial teams and broader Clinical Operations into ongoing work through tracking of clinical trial performance * mai