Sr. Clinical Trial Manager

1 month ago

Redwood City, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:
  • Act as the study lead delegate on cross-functional study teams, Vendor, and CRO operational meetings and ensure compliance with global operational standards and procedures.
  • Support vendor selection, onboarding, management, and oversight of multiple vendors including but not limited to CRO (including RFPs and bid defense for CRO and finalization of SOW), imaging, central and specialty labs, eCOA, and compliance.
  • Manage vendor operational meetings to ensure project goals and timelines are met.
  • Assist with or be responsible for the management of key study parameters (e.g., start-up activities, site feasibility, enrollment, site management, data collection, data review, database lock, etc.) and proactively identify solutions within the clinical team when issues arise.
  • Responsible for study start-up, including working with cross functional teams on startup, and with the CRO on site selection/activation.

Requirements:

  • As a Contract Clinical Trial Manager, you will be responsible and accountable for managing operational activities for assigned studies and may assume responsibility for additional vendors, studies and/or clinical programs, as they become available.
  • The Clinical Trial Manager provides operational leadership to ensure the study milestones are delivered on time, within budget, with high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs.
  • The Contract Clinical Trial Manager will help establish new processes and work instructions to ensure consistent, effective, and efficient execution of clinical operation activities.
  • The Contract Clinical Trial Manager will partner with key stakeholders (internal and external) to ensure continuous harmonized operations of clinical operations activities and to maintain high standards for performing in a cross-functional environment.

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