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Position description:
1. Responsible for trial design, planning (timeline and budget) and accountable for clinical study projects in China territory of Qiagen organization by coordinating with activities and stakeholders internally and externally.
2. Ensure compliance to SOPs, GCP policy, and relevant CFDA regulations in the operation of clinical study.
3. Responsible for tracking of timeline and budget, ensuring complete trial in a timely manner within budget, and raise up potential issues timely, setup internal and external communications for correction, trouble shooting, and prevention plan.
4. Draft and implement all study associated documentation including ethical application, CFDA files of trial, study protocols, contracts, site files, audit reports, and study reports.
5. Review all source documentation, monitor reports, site record, and data for accuracy and ensure timely submission and safe storage of all documentation.
6. Execute site survey/selection, guide lab preparation, instrument/reagent setup, kick-off meeting/training, logistic of consumables supply and inventory in line with regulations.
7. Lead CRA/CRC (internal and external) to plan site monitoring, and ensure good monitoring quality in terms of documentation, enrollment progress, data records. Lead data specialist for database design, database implementation on site, integrity check planning, and statistic strategy.
8. Coordinate communications with investigators, and participate discussions with CFDA relevant reviewers / guideline drafter if necessary
Hiring requirement/preference:
1. At least 4 years IVD clinical trial related experiences, Pharma trial experiences could be considered as well, better clinical project management roles.
2. Strong and solid IVD or bio-tech knowledge, medical or clinical lab related backgrounds preferred.
3. Proficiency of English oral communication, and technical reading and writing.
4. Excellent knowledge in CFDA regulation, ISO international standards, and relevant clinical trial guidance.
5. Strong ability in inter-personal skill, project management skill, problem-solving mindset