Clinical Project Manager/ Sr Project Manager

Theradex Oncology•Princeton, NJ

5d•$105,000 - $165,000•Remote

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 to work with industry sponsors developing cancer therapeutics, supporting both domestic and international sponsors in early and late phase trials. This role offers the opportunity to work with a large professional team focused on cancer therapy development, supporting sponsors in the development of new therapies and therapeutic approaches. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

Requirements

BS required– preferably in a life science field or equivalent (includes RN degree)
Healthcare professional with at least 4 years of clinical experience, or Science Graduate with at least 4 years experience in clinical research, with a track record in successfully managing clinical trial sites
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
Must be fluent in English (verbal and written)
Well-developed critical thinking and analytical skills, with the ability to anticipate problems relating to projects and to develop and implement solutions
Able to seek out multiple and diverse perspectives; open to continuously refining your approach based on feedback and new information
Knowledgeable of the initiation, conduct, and completion of clinical trials, study endpoints, and clinical databases
Well-developed and effective written and verbal communication skills, including report writing, preparing, and delivering presentations, and various correspondence and meeting platforms
Effective knowledge of the drug development process

Nice To Haves

MS. or PhD. preferred
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)
Ability to travel occasionally up to 30% when required, domestic and/or global
Valid Driver’s License an advantage
Basic knowledge of one (or more) European language an advantage

Responsibilities

Oversee global phase I – III oncology clinical trials from feasibility and startup through closeout to ensure processes, timelines, contracts, ICH/GCP adherence and quality standards are met.
Serve as the key point of contact, interfacing directly with sponsors, vendors, cross-functional team members and investigative sites.
Identify and evaluate risks, interpret data on complex issues and implement solutions to ensure successful completion of oncology trials.
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.