(Sr)Clinical Trial Manager (Shanghai, China)

About Innovation Unit China

Innovation Unit China (China R&D Center) is a strategic innovation hub within Boehringer Ingelheim’s global R&D network, established to harness China’s rapidly evolving scientific capabilities and vibrant innovation ecosystem. By integrating Experimental Medicine, External Innovation, Development CMC, and Clinical Pharmacology & Non-clinical Safety Science, IU China connects promising science with early development expertise to accelerate high-potential opportunities, contribute to the global pipeline, and help accelerate breakthrough therapies for patients in China and around the world.

Responsibilities

- Trial Preparation

Accountable for the trial activities for responsible R/OPU, including but not limited to:

• Ensure the trial is conducted in compliance with GCP-ICH, local/global regulations, applicable SOPs and according to the trial protocol by overseeing CRO and internal team activities.

• Creation, management and review of the R/OPU trial budget to ensure appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes.

• Appropriate trial-specific training of R/OPU internal and external partners is performed in line with Trial Training Plan.

• Accurate planning and co-ordination of operational feasibility of trial timelines for their R/OPU; and oversight of trial preparation to ensure trial team members are aligned and on track.

• Verifies and provides input into the country and site level feasibility and OPU commitment (site and patient commitment). Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions (i.e. Medical Affairs, vendors if applicable).

• Development and implementation of country level engagement plans, recruitment planning and risk mitigation. Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders. Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value

• Frontloading of activities where possible at the R/OPU level to facilitate efficiencies as well as to ensure and leverage speed.

• Oversees outsourcing of vendor services in the R/OPU in accordance to operating models and governance.

• Ensure timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders.

- Trial Conduct

• Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation.  In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, and safety reporting.

• Monitor progress of patient recruitment endpoints and proactively update and action contingencies throughout trial conduct.

• Contribute to investigator meetings and fully responsible for the leading and facilitating local investigator meeting

• Establish and maintain relationships with external experts, investigational sites, Patient Organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst CD&O and appropriate functions (i.e Medical Affairs, Market Access, etc.) on regional/ local level.

• Active participation in the CDO community with a special focus on participating in the CTM network, to actively contribute to functional excellence.

- Trial Closeout and Reporting

• Ensures timely cleaning and delivery of clinical trial data.

• Responsible for timely, complete and compliant archiving of all relevant R/OPU documents in the TMF, including all required documents from vendors.

• Ensures timely submission of the CTR to Regulatory Authority/Ethics Committee and other external stakeholders as required by local regulations

• Shares information on trial results with Investigational sites and, if applicable, Patients (e.g. lay summaries).

- General accountabilities

• Build and maintain engagement with Investigators, other site staff and Patient Organizations (POs), in collaboration with other functions, to ensure trial speed and effective start up, conduct and close out.

• Establish and maintain relationships with external experts, investigational sites, Patient Organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst CD&O and appropriate functions (i.e Medical Affairs, Market Access, etc.) on regional/ local level.

• Ensure issues are raised to Evidence team for timely action or mitigation.

- Leadership Competencies

• Creates an environment that inspires, motivates, and empowers colleagues and promotes one common CDO identity, contributing to acceleration of clinical development timelines and value creation for patients

• Fosters a learning culture in CDO regions by encouraging continuous learning, sharing best practices, and learning from failures.

• Embraces innovative approaches and technologies, as well as creates and maintains a culture that drives empowerment, smart risk taking and one common CD&O identity.

 

Qualifications

- Masters degree or comparable degree with several years relevant experience in required area. Major focus: Biomedical Life Sciences

- 8+ years of relevant experience in the clinical research field with 3-5 years of experience in clinical project management

- Strong Communication Skills: Demonstrates Our Behaviors approach and skills in complex cross-functional matrix structures of the trial and extended team. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Demonstrates active listening skills and cultural awareness.

- Scientific and Operational Expertise: Demonstrates scientific and therapeutic knowledge and operational expertise across all aspects of clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors.

- Leadership and Influence: Demonstrates skills and capabilities in addressing complex situations, confidently setting direction for teams. Demonstrates leadership behaviours of supporting, connecting and empowering teams, providing future direction, demonstrating visionary and innovative thinking and inspiring teams to achieve a common goal. Executes activities with a clear aim to deliver value to patients.

- Strategic Mindset: Strategic and visionary thinker who is future focused, creative, courageous and able to navigate through ambiguity. Integrates study strategy with overall TA portfolio. Embraces cross functional initiatives, applying innovative learnings. Is results-oriented with a global mindset using analytical thinking to provide risk-balanced solutions.

- Coordination and Oversight: Collaborative leader who demonstrates skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources.

- Project Management: Plans effectively, setting priorities, and defining actions. Makes effective use of resources, and proactively strives for transparency and clarity to accomplish the business deliverables. Translates complex situations to actionable parts.  Anticipates and resolves challenges and translates learnings to new projects. Takes smart risks.