Clinical Project Manager/ Sr Project Manager

Who We Are:

Celebrating 40+ years!

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.

What You'll Do:

REMOTE - US

Clinical Project Manager or Sr Clinical Project Manager based on experience. Experience with oncology trials is highly preferred.

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

What You Need:

• Must be fluent in English (verbal and written)
• 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
• Experience with oncology clinical trials and/or cancer therapies highly preferred
• Experience working with CAR T-cell clinical trials highly preferred
• Prior experience in a CRO/pharmaceutical environment preferred (required for senior level project managers)

• 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

• 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

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.

Theradex is an Equal Opportunity Employer.

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