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Lead Clinical Research Associate

Clinical Trials Manager (CTM) (2-3 days of remote flexibility)

Position Summary:

Seeking a team player to join a 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, and document management and data review activities in accordance with standard operating procedures, clinical operational plans, regulatory requirements and Good Clinical Practice.

Responsibilities:

  • 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 pre-study site evaluations as well as new site initiations and trainings
  • Assists in the development and management of study budgets, timelines 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
  • Initiates and manages cross-functional meetings to ensure alignment with all program stakeholders
  • 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
  • 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 preferred
  • Demonstrated computer aptitude in MS Office Suite and other systems
  • Good working knowledge of management and oversight of CROs and TMFs
  • Accommodates a flexible work schedule according to clinical trial(s) priorities
  • Strong interpersonal, organizational and multi-tasking skills; attention to detail

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