Clinical Project Manager

1일전에

Seoul, 대한민국 beBeeClinical 풀타임
Job Title: Clinical Project Manager

We are seeking an experienced Clinical Project Manager to oversee the successful conduct of clinical trials in various therapeutic indications. As a key member of our team, you will be responsible for coordinating project timelines, patient enrollment, and ensuring compliance with regulatory requirements.

The ideal candidate will have a strong background in clinical research, excellent communication skills, and the ability to work effectively in a dynamic team environment. If you are a motivated and organized individual with a passion for clinical project management, we encourage you to apply for this exciting opportunity.

Key Responsibilities:
  • Coordinate investigator/site feasibility and identification process, as well as study startup.
  • Monitor project timelines and patient enrollment, implement respective corrective and preventive measures.
  • Review monitoring visit reports for all visit types and ensure reporting compliance of the Monitors in the region.
  • Manage Monitors in the query resolution process, including Central Monitoring observations.
  • Coordinate safety information flow and protocol/process deviation reporting.
  • Perform clinical supplies management with vendors on a country and regional level.
  • Ensure study-specific and corporate tracking systems are updated in a timely manner.
  • Act as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/or Project Manager.
  • Coordinate planning of supervised monitoring visits and conducts the visits.
  • Manage the project team in site contracting and payments.
  • Lead project team calls on a country level as well as provide status updates and reports to Regional Lead/Project Manager.
  • Ensure ongoing evaluation of data integrity and compliance at a country/regional level.
  • Conduct site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
  • Oversee project team in CAPA development and implementation.
  • Coordinate project team in process deviations review, management and reporting.
  • Conduct initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
  • Provide project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
  • Delivers trainings and presentations at Investigator Meetings.
  • Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
  • Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
  • Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
  • Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
  • Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
  • Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF)/TMF at site level and country/region level.
  • Ensures data integrity and compliance at a site level.
  • Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/Regional Lab/Central Reviewer.
  • Conducts project-specific training of site Investigators.
  • Supports preparation of draft regulatory and ethics committee submission packages.
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