US-NJ-Princeton | US ID 2024-1339 Category Clinical Project Management Type Full Time
Who We Are
Celebrating 40+ years!
Theradex Oncology is a full-service CRO, conducting early- and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.
Theradex Project Managers oversee global phase I – III clinical trials from feasibility and startup through closeout to ensure processes, timelines, contracts, ICH/GCP adherence and quality standards are met. As a primary point of contact, our project managers are hands-on and interface directly with sponsors, vendors, cross-functional team members and investigative sites. They identify and evaluate risks, interpret data on complex issues and implement solutions to ensure successful completion of oncology trials.
What’s in it for you?
Theradex Oncology is a leading global oncology CRO, in business for over 40 years. We support many of the most prominent pharmaceutical and biotech companies in the industry with promising new molecules that address a wide range of oncology indications. We provide a supportive environment through our expertise, innovative systems and processes and we give you the tools to be successful as we grow our Clinical Operations Team.
The primary responsibilities of this position include, but are not limited to, the following:
Clinical Operations:
Proactive management and execution of clinical projects to ensure issues are identified and solutions established
Provide oversight, support, and guidance for the Theradex study team through across departments
Serve as protocol subject matter expert for assigned study
Contribute to the development of standard metrics used to routinely monitor study activities
Day-to-day management of the study team as required, including leading team meetings and provision of study training
Provide training of Theradex procedures to staff
Assume other project responsibilities as needed
Study Conduct:
Monitor study enrolment and retention; act on deviations from plans
Identify barriers to enrolment; develop and support strategic recruitment and retention solutions
Monitor and act upon study metrics (trend-identification and analysis, with targeted follow up where appropriate)
Review Monitoring Visit Reports
Ensure accuracy of study information presented in status reports and clinical trial platforms
Risk Assessment & Mitigation:
Proactively identify and communicate Clinical Operations risks and mitigations and align with study team on overall Risk Mitigation Plan
Quality:
Establish study-specific oversight plans and ensure review and adherence
Ensure protocol deviation meetings are conducted per plan.
Facilitate internal audit / corrective and preventive action (CAPA) management, and contribute to the resolution of the CAPA
Manage TMF filing of Clinical Operations documentation
Conduct or participate in inspections readiness activities and audits in collaboration with QA
Contributes as appropriate to Theradex SOPs and management activities
Timelines:
Proactive management of study specific timelines to ensure activities occur as contracted
Budget:
Review and manage the study budget and scope of work; ensure quarterly budget review meetings are performed
Work proactively to ensure the study remains within the agreed scope and budget
Initiate Change Order (CO) activities as required
Conduct monthly invoice and timesheet reviews
What You Need
Requirements:
Must be fluent in English (verbal and written)
BS. required– preferably in a life science field or equivalent (includes RN degree) MS. or PhD. preferred
Healthcare or industry professional with at least 3 years of clinical/industry experience, or Science Graduate with at least 3 years’ experience as a Clinical Research Associate / Senior Clinical Research Associate, 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
Experience with oncology clinical trials and/or cancer therapies preferred
Prior experience in a CRO/pharmaceutical environment preferred
Skills and Competencies
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
What We Offer
We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, short term and long term disability (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.
Relocation assistance or company provided sponsorship is not offered for this position.
