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.   

We are looking for a Clinical Project Manager or Sr Clinical Project Manager (dependent upon experience) to oversee high-impact clinical studies on behalf of our sponsors. This position is remote and requires occasional travel for meetings.

Senior Project Manager candidates must have oncology experience.

Theradex Project Managers 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. 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.

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

Qualifications:

• Education: BS. required– preferably in a life science field or equivalent (includes RN degree) MS. or PhD. preferred

Requirements:

• You must have proven experience with oncology clinical trials and/or cancer therapies (for senior level role) and highly preferred for the project manager 
• Prior project management experience required
• Must be fluent in English (verbal and written)
• Prior project management experience required
  • 5+ years of prior project management experience with demonstrated leadership skills in a CRO/pharmaceutical environment, with a track record in successfully managing clinical trial sites for Sr level.
  • 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 for project manager role. 
• Prior experience in a CRO/pharmaceutical environment required (for Sr level) 
• High level of proficiency with Excel and MS Office; ability to master various electronic platforms for data entry and clinical trial management
• Experience with CAR-T cell therapy/trials highly 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

Additional Requirements

• 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

Relocation assistance or company provided sponsorship is not offered for this position.

What We Offer

At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes 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 and other company provided benefits. The annual base salary for this position ranges from $105,000-$165,000 with bonus potential. We will assess the specific title and level of entry during the interview and assessment process since the actual salary offer will be based on a number of factors, including but not limited to the candidate’s qualifications, experience, skills, and competencies for the role.

Theradex is an Equal Opportunity Employer.