Clinical Affairs Supervisor
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What you'll do
- Provides clinical strategy support for clinical evaluation, study design, oversea clinical data analysis & submission.
- Protocol writing, collaborates on the statistical analysis plan/data management plan, monitoring plan.
- Plans, implements, and manages clinical trials, and interprets results.
- Defines clinical trial protocols, standard operating procedures (SOPs) and case report forms (CRFs) in clinical operations.
- Manages the budget & recommending resources to support projects, effectively drives action plan deliverables to OTD.
- Sets up new clinical sites for responsible clinical trials, keeps good relationship with investigators, KOLs.
- Organizes and manages clinical investigator meetings.
- Data analysis & presentation to internal and external stakeholders, contribution to clinical reports and peer-reviewed publications.
- Responsible for multiple product lines for project management and quality control for registrational clinical trial.
- Give leadership for team members for clinical trial development.
- Give co-monitoring and trial quality control to ensure clinical trials meet NMPA requirements.
- Keeps effective collaboration across functions (biostatistics, data management, regulatory, quality, R&D etc.) and external partners.
What they're looking for
- Clear understanding of NMPA regulation and IVD and CDx clinical trial requirements.
- Experience in clinical strategy support for clinical evaluation, study design, and clinical data analysis.
- Experience in protocol writing, statistical analysis plan/data management plan, and monitoring plan.
- Experience in planning, implementing, and managing clinical trials.
- Experience in defining clinical trial protocols, standard operating procedures (SOPs) and case report forms (CRFs).
- Experience in managing budgets and recommending resources.
- Experience in setting up new clinical sites and managing relationships with investigators and KOLs.
- Experience in data analysis and presentation to internal and external stakeholders.
- Experience in project management and quality control for registrational clinical trials.
- Experience in cross-functional collaboration (biostatistics, data management, regulatory, quality, R&D).
- Experience in managing external partners (investigators, subject matter experts, Contract Research Organizations).
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Clinical evidence strategy – Provides clinical strategy support for clinical evaluation, study design, oversea clinical data analysis & submmision etc. to better evaluate clinical safety and effectiveness of product concept/prototype/final product prior to product launch.
• Study design – Protocol writing, collaborates on the statistical analysis plan/data management plan, monitoring plan. • Study execution – Plans, implements, and manages clinical trials, and interprets results. Defines clinical trial protocols, standard operating procedures (SOPs) and case report forms (CRFs) in clinical operations. • Study execution – Manages the budget & recommending resources to support projects, effectively drives action plan deliverables to OTD.
• Study execution – Sets up new clinical sites for responsible clinical trials, keeps good relationship with investigators, KOLs.
• Study execution – Organizes and manages clinical investigator meetings.
• Study reporting – Data analysis & presentation to internal and external stakeholders, contribution to clinical reports and peer-reviewed publications.
• Be responsible for multiple product lines for project management and quality control for registrational clinical trial, give leadership for team members for clinical trial development. Give co-monitoring and trial quality control to ensure clinical trials meet NMPA requirements.
• Keeps effective collaboration across functions (biostatistics, data management, regulatory, quality, R&D etc.) and external partners (investigators, subject matter experts, Contract Research Organizations) on product development process deliverables.Good interface with government agency, cultivate relationship with vendors, consultants, contractors, and professional associations, engage in NMPA consultation, be clear with NMPA regulation and IVD and CDx clinical trial requirements.
• Drives sustainment & improvement of functional standard work.
• Maximizes the Danaher Business System (DBS) and tools to develop and deliver high-quality Global Clinical Affairs (GCA) standard work processes.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
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