Clinical Project Manager or Director 部门:Clinical Development  工作类型:Full time, Employee
工作地点:Shanghai, China
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Overview:

Clinical Project Manager or Director will be accountable for the implementation, management and reporting of assigned clinical trials. In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP) and in accordance with the International Conference of Harmonization (ICH) Guidelines. Will be a key member of the clinical project team working closely with the Medical Leader and other key functions, and will be accountable for all aspects of assigned study execution including where applicable, CRO selection, study plan design, execution, study start-up, CRO and vendor management and performance, study budget and timelines. Develops all study plans in collaboration with the CRO. Manages all aspects of clinical operational plan.


Responsibilities:


  • Ensure successful completion of clinical studies that are on time and within budget.
  • Accountable for ensuring all needed aspects of clinical operations are identified (drug, resources, contracts, budgets, etc) and planned in timely manner. Generate contingency plans where necessary, proactively identify potential issues/risks and mitigate.
  • Manage and monitor performance of all CROs and vendors to ensure successful completion of program with regard to timelines and budget.
  • Manage the budget, contract requirements, and performance metrics for the team to ensure that trials/development program plans are on target.
  • Work with DM to develop data capture tools that reflect the requirements of the protocol.
  • Review clinical data and metrics to identify trends.
  • Develop mitigation plans as necessary.
  • Review and approve clinical supply and dispensing design and drug labels.
  • Liaise with CRO on Investigational Review Boards (IRBs) and Ethics Committees (ECs) requirements and questions.
  • Review and contribute to key study documents including protocols, case report forms (CRFs) and Informed Consent templates.

Qualification:


  • Bachelor's degree in Life Sciences, Pharmacy or Life Sciences. Advanced degree preferred.
  • At least 5 years of experience working in industry and or with a CRO is required-managing clinical studies. The director must be able to work collaboratively with others both internally and externally. Oncology experience preferred.
  • Good working knowledge of GCP and ICH guidelines.
  • Title and compensation commensurate with qualifications and experience.
  • Proactive and organized with exceptional follow-up.
  • Anticipate/ identify problems and takes appropriate action to correct.
  • High degree of accuracy with attention to details.
  • Excellent team player.