Clinical Study Associate Manager

1 month ago

Shanghai, Shanghai, China Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch Full time
Job Summary

We are seeking a highly skilled Clinical Study Associate Manager to join our team at Stryker (Beijing) Healthcare Products Co. Ltd - Shanghai Branch. The successful candidate will be responsible for managing clinical studies from start to finish, ensuring that all aspects of the study are conducted in accordance with Good Clinical Practice (GCP) and local regulations.

Key Responsibilities
  • Develop and execute clinical project plans, including scope, timeline, budget, resources, and risks.
  • Manage day-to-day activities of one or more clinical studies, ensuring that all aspects of the study are conducted in accordance with GCP and local regulations.
  • Interface with cross-functional teams, including clinical, divisional, and external stakeholders, to ensure seamless communication and collaboration.
  • Provide guidance and training to clinical staff, including Clinical Study Associates (CSAs) and Clinical Research Associates (CRAs).
  • Lead and manage diverse teams of clinical staff, ensuring that all team members have the necessary resources and support to perform their duties effectively.
  • Contribute to the development of trial synopses, protocols, and amendments, ensuring operational feasibility and compliance with regulatory requirements.
  • Facilitate the development of trial synopses and protocols, and develop project plans, ensuring that all aspects of the study are conducted in accordance with GCP and local regulations.
  • Coordinate and support monitoring activities, ensuring that all data is collected and validated in a timely manner.
  • Work with trial project teams to assess project risks and issues, and develop strategies to mitigate these risks.
  • Communicate study results and updates to various internal stakeholders, as needed.
  • Recruit, select, and onboard high-quality staff, ensuring that all team members have the necessary resources and support to perform their duties effectively.
  • Lead clinical resourcing, ensuring that all team members have the necessary resources and support to perform their duties effectively.
  • Evaluate quality of work for various job roles and specialized functions, ensuring that all team members are meeting or exceeding performance expectations.
Requirements
  • Bachelor's level degree or equivalent in a science or healthcare field, with at least 6 years of relevant clinical research experience, preferably in clinical study management.
  • Preferred experience in the Device or Pharmaceutical industry.
  • Preferred clinical research or project management certification, such as CCRP, ACRP, or PMP.
  • Well-organized and detail-oriented, with strong written and verbal communication skills.
  • 2-4 years of project management experience in clinical studies, and 2-4 years of monitoring experience in clinical studies.

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