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Clinical Project Manager

2 months ago

Raleigh, United States D2V Clinical Full time
Job DescriptionJob Description

This is a remote position.

We are recruiting for a Contract Clinical Project Manager to help 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. Founded by seasoned veterans from the industry and the FDA, D2V Clinical focuses on asset value creation for sponsors. The company offers vast knowledge and insight to expedite program advancement and ultimately, to get better medicines to patients as efficiently as possible.

The Clinical Project Manager (CPM) is responsible for the management of all aspects of Clinical Trial Team activities for assigned project(s). The CPM, in concert with the Head of Clinical Operations is accountable for achieving successful delivery of clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.

Some of the things you will do in this role at D2V Clinical:
  • Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors.
  • Provide efficient updates on trial progress to the Clinical Program Director (CPD) and/or Senior Director of Clinical Operations (DCO), with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
  • Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
  • Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
  • Ensure potential study risks are escalated to the attention of the CDP when appropriate.
  • Chair CTT working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.
  • Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
  • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.
  • Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner.
  • Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
  • Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.
  • Effectively provide support to Clinical Site Manager(s) in the conduct of the trials.


Requirements
  • Bachelor’s degree, and a minimum four (4) years of clinical operations experience; with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required or an equivalent combination of education and experience.
  • Proficiency in Microsoft Office Suite.
  • Working knowledge of various clinical systems (e.g., 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 face-paced, highly interactive environment.
  • Self-starter and independent learning ability.
  • Ability to work independently and in a team environment.
  • Strong communication skills (verbal and written) to express complex ideas to multidisciplinary teams and/or management.
  • Up to 20% travel may be required domestically.

Benefits

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