Clinical Project Manager

2 days ago


Raleigh, North Carolina, United States D2V Clinical Full time
Job Description

This is a remote position for a Contract Clinical Project Manager to support our clients throughout the various phases of our projects.

Dose2Value Clinical (D2V Clinical) is a full-service global CRO addressing the challenges of early-phase studies faced by biotech companies.

The Clinical Project Manager is responsible for the management of all aspects of Clinical Trial Team activities for assigned project(s).

Key responsibilities include:

  • Proactively managing project level operational aspects of Clinical Trial Team, including management of trial timeline, budget, resources, and vendors.
  • Providing efficient updates on trial progress to the Clinical Program Director and/or Senior Director of Clinical Operations.
  • Leading sponsor study startup process, including conduct of the Trial Kick-off meeting, set-up of trial master file, site selection, and finalization of site and vendor Clinical Trial Agreements and budgets.
  • Ensuring effective project plans are in place and operational for each trial.
  • Chairing CTT working group and vendor status update meetings.
  • Reviewing and approving site visit reports, tracking, follow-up, and resolution of site issues.
  • Monitoring the quality of vendor deliverables and addressing quality issues.
  • Reviewing and approving vendor invoices and responses to quality assurance audits.
  • Ensuring all project level study documentation is filed in the TMF in accordance with company SOPs and regulatory requirements.

Requirements:

  • Bachelor's degree and a minimum four (4) years of clinical operations experience in the Pharmaceutical, Biotechnology, Medical Device, or CRO industry.
  • Proficiency in Microsoft Office Suite.
  • Working knowledge of various clinical systems, including electronic data capture (EDC).
  • Knowledge of guidelines, ICH-GCP, and other applicable local and international industry regulations.
  • Attention to detail, highly organized, and the ability to multitask and prioritize in a fast-paced environment.
  • Self-starter and independent learning ability.
  • Ability to work independently and in a team environment.

This is an independent contractor role and is not eligible for employee benefits.



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