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Clinical Trials Manager

Clinical Trials Manager (CTM)- Newton, MA (1-2 Days of Remote Flexibility)

Position Summary:

Seeking a team player with excellent interpersonal and organisational skills to join our growing clinical operations team. They will be responsible for managing clinical trial/s from protocol concept through the clinical study report, providing clinical trial coordination support including clinical status tracking, SAE reconciliation, document management and data review activities in accordance with standard operating procedures, clinical operational plans, regulatory requirements and Good Clinical Practice.

Responsibilities:

  • Ensures clinical trial/s are executed in compliance with ICH/GCP (Good Clinical Practice) guidelines, regulations, and company SOPs
  • Assists in vendor RFPs, bid compilation and contract management and execution
  • Assists in the selection, qualification, and management of vendors and sites to support clinical trial execution
  • Assists in the development and management of study budgets, time lines and metrics; ensures completion of study deliverables; provides status update reports
  • Plans the requirements for clinical trial material
  • Plans and executes study-specific meetings (e.g., investigator meetings) as needed
  • Assists with preparing basic summary reports, Serious Adverse Event/Adverse Event reconciliation for PVG
  • Reviews all SAEs, ensuring Medical Director sign-off, that sites are notified and that company procedures are followed
  • Reviews monitoring reports to ensure quality and resolution of site-related issues
  • Ensures tracking and review of protocol deviations and assesses impact on study data
  • Partners with clinical scientists to design clinical trial protocols consistent with the clinical development plan
  • Participates in departmental planning sessions, and SOP development
  • Manages clinical trial vendor and site relationships
  • Oversee management of CRF data (EDC), trial-related documents in the Trial Master File (TMF)

Competencies/Requirements:

  • Bachelor's degree in life sciences or related area preferred
  • 2+ years of relevant work experience in clinical trial management in a pharmaceutical or CRO environment preferred
  • Working knowledge of ICH/GCP regulations and clinical protocols
  • Demonstrated computer aptitude in MS Office Suite and other systems preferred
  • Good working knowledge of management and oversight of CROs and TMFs

Sthree US is acting as an Employment Agency in relation to this vacancy.