Clinical Research

• Lead and Drive study delivery in China
• Support in preparation of regular status reports to local DCO and global CTM/Platform Lead, including presentation of project status in meetings
• Overlooking the clinical operation trial budget in country level
• Opportune contact with PM and ADCO in case of divergences from the project plan
• Oversight on project timelines and deliverables in country level
• Set-up or oversight of study related documents such as Trial Management Plan, Monitor Manual, etc.
• Contribution to and review of study core documents and contribute to local customization, e.g. synopsis, investigator’s brochure, patient informed consent documents etc.
• Coordination of project activities with other internal departments or external vendors from start-up to close out of a clinical trial
• Support in planning and conduct of project training prior to starting project activities, oversight
• Responsible for the execution of clinical trials, mainly with regard to operational and administrative aspects.
• This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs.
• S/he performs activities related with leading the operational project team, the supervision/ control of third party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved
• Support on clinical operational function development in China with the guidance of DCO, including but not limited to support on GCO initiative delivery in China
• China KOL engagement ability with the support from clinical dev and GMA
• Engage with and provide oversight to our CRO partners in China
• CRO and other vendor (including but not limited to SMO, referral company, QC/QA vendor, etc.) collaboration and oversight to ensure the high quality and full compliance
• Ensure the quality and integrity of outsourced clinical trials
• Actively identify and manage any internal and external risks to the business
• Build and maintain strong relationships with local vendors including but not limited to CROs, patient advocacy groups and SMOs at strategic and operational levels
• Build processes and actively support CROs to achieve best in class site activation timelines for outsourced trials in China
• Work on the efficient collaborations with our strategic development partners in China
• Provide operational oversight of joint clinical trial programs including verifying partner company SOP, system, staff qualification, etc.
• Serve as a point of escalation in case of challenges in project activities
• Play an active role in helping to bridge cultural gaps and language barriers.

Senior Manager, Clinical Trial Management

• Responsible for the delivery of all clinical aspects of the study
• Oversees the clinical portion of the budget
• Develops monitoring plans & tools
• Trains CRAs
• Drives enrolment and study start-up activities
• Reviews trip reports
• Implements corrective and preventative action plans
• Liaises with the Sponsor, vendors & cross-functional teams
• Identifies & mitigates risks that may impact clinical delivery
• Provides reporting & metrics on all clinical activities
• Participates in Sponsor, Investigator and bid defense meetings

Clinical Trial Manager

• Leadership of group work and building the team spirit, including developing team style and behaviour.
• Ensuring adequate resources for the studies assigned.
• Ensure that the workload of the team(s) or direct reports is adequate.
• Ensure all direct reports comply with company policy and code of conduct.
• Development and performance management of the team(s) or direct reports.
• Ensure that everyone in the team or direct reports have development and training plans, according to IDP process.
• Contribute to high quality feasibility work.
• Contribute to efficient SMOT organisation and its functioning at country level by working closely with responsible SMOT Director.
• Contribute to the quality improvement of the study processes and other procedures.
• Plan and organise coaching of the team members and all direct reports.
• Ensure that the individual performance planning and review process is completed for all direct reports.
• Prepare salary and bonus proposals of all team members or direct reports based on their performance in close collaboration with responsible SMOT Director and HR partner.
• Ensure all systems are continuously updated.
• Support direction to LSM/teams on major study commitments including resolving any key issues identified.
• Review of monitoring reports/follow up letters to evaluate all direct reports capability as needed.
• Perform necessary accompanied site visits for direct reports, supporting ongoing coaching and development.
• Support SMOT region in initiatives/activities as agreed with SMOT Director(s).
• Assist SMOT director to drive cross team projects, contribute more to team/org. learning, etc.

Clinical Research jobs in China

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Senior Manager, Clinical Trial Management

Clinical Trial Manager

Associate Clinical Research Manager