Be accountable for the planning, implementation, management and reporting of clinical trials, which may not only in China, but included overseas. Lead the clinical studies are executed in conformance with Good Clinical Practices (GCP) and in accordance with the International Conference of Harmonization (ICH) guidelines. Take responsibilities of CRO and vendor selection, collaboration, management and performance.
ESSENTIAL JOB RESPONSIBILITIES:
Develop clinical trial strategy and plan in collaboration with CRO and internal functions.
Ensure successful completion of clinical studies that are on time, within budget and with high quality. Accountable for ensuring all needed aspects in clinical operations (drug, resources, contracts, budgets, trainings, meetings, documentations, etc.) are identified, planned and implemented in time. Proactively identify potential issues/risks, generate contingency plans and mitigation plans when necessary.
Manage and monitor performance of all CROs and vendors to ensure successful completion of drug development program with regard to timelines, budget and quality.
Review and contribute to key study documents including protocols, case report forms (CRFs) and Informed Consent templates.
Review and analyze clinical data and metrics to identify trends.
Bachelor or above degree in Life Sciences, Pharmacy, Clinical Medicine or related major
Above 3 years working experience in managing clinical trials projects and operation
Good working knowledge of GCP and ICH guidelines
Rich experience in collaboration with CRO in Clinical Projects
Plenty knowledge and project experience in early phase clinical studies
International multi-center projects experience is preferred
Proactive and organized with ability to follow up
Anticipate/ identify problems and takes appropriate action to correct
Strong sense of ownership and attention to details
Excellent team player