Clinical Project Manager/ Sr Project Manager

Theradex OncologyNJ
109d$105,000 - $165,000

About The Position

Theradex Oncology is a full-service CRO specializing in oncology, managing global oncology trials and programs. Founded in 1982, the company has expanded from working with the National Cancer Institute to collaborating with industry sponsors in developing cancer therapeutics. As part of Theradex Oncology, you will work with a professional team focused on the development of cancer therapies, supporting sponsors in this evolving field. The position is for a Clinical Project Manager or Sr Clinical Project Manager, depending on experience, and is remote within the USA. Project Managers oversee global phase I – III oncology clinical trials, ensuring adherence to processes, timelines, contracts, ICH/GCP standards, and quality.

Requirements

  • BS required, preferably in a life science field or equivalent (includes RN degree).
  • MS or PhD preferred.
  • Healthcare professional with at least 4 years of clinical experience, or Science Graduate with at least 4 years experience in clinical research.
  • Prior project management experience required.
  • High level of proficiency with Excel and MS Office; ability to master various electronic platforms for data entry and clinical trial management.
  • Experience with oncology clinical trials and/or cancer therapies is highly preferred (required for senior level project managers).
  • Prior involvement with CAR-T or other gene/cell therapies is highly preferred.
  • Prior experience in a CRO/pharmaceutical environment preferred (required for senior level project managers).
  • Must be fluent in English (verbal and written).

Nice To Haves

  • Basic knowledge of one (or more) European language.
  • Valid Driver’s License.

Responsibilities

  • Drive the successful execution and proactive management of clinical projects.
  • Serve as the subject matter expert for assigned protocols and provide guidance to cross-functional study teams.
  • Monitor study enrollment, retention, and metrics to identify trends and act on deviations.
  • Develop and implement strategic solutions for recruitment and retention challenges.
  • Ensure accurate study information is reflected in status reports and clinical trial platforms.
  • Proactively identify and communicate operational risks, aligning with the study team on mitigation strategies.
  • Oversee the development and adherence to study-specific oversight and Corrective and Preventive Action (CAPA) plans.
  • Manage the Trial Master File (TMF) for Clinical Operations documentation and ensure inspection readiness.
  • Collaborate with Quality Assurance for internal and external audits.
  • Proactively manage study-specific timelines and budgets.
  • Review and approve invoices and timesheets.
  • Identify and initiate Change Order (CO) activities as required to maintain project scope.
  • Lead and manage the day-to-day activities of the study team, including leading team meetings and conducting study-specific training.

Benefits

  • Medical, dental and vision coverage.
  • Life insurance.
  • Disability insurance (STD/LTD).
  • Company matched 401(k).
  • Very competitive tuition reimbursement.
  • Generous vacation/sick plans.
  • Flexible work schedules.
  • Employee discounts.
  • Other company provided benefits.
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