Clincial Project Manager/Sr

Theradex Oncology; United States; On-site; USD 105,000 - 165,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Life and disability insurance

401(k) with company match

Tuition reimbursement

Generous vacation/sick leave

Flexible work schedules

Employee discounts

Job summary

Theradex Oncology, a full-service CRO specializing in oncology, seeks a Project Manager to lead global phase I–III trials from startup to closeout. You will interface with sponsors, vendors and sites, drive timelines, budgets, risk management, and CAPA plans, and ensure ICH/GCP compliance.

Travel up to 30% may be required. Responsibilities include leadership of study teams, oversight of enrollment and metrics, TMF management, and collaboration with QA for audits.

Qualifications

• BS in life science or equivalent; RN degree considered.
• MS/PhD preferred.
• At least 4 years of clinical experience; 5 years for Sr level.
• Experience with oncology trials and/or cancer therapies preferred.
• CRO/pharma environment experience preferred for Sr level.
• Fluent in English (verbal and written).
• Ability to travel up to 30% domestically and globally.

Responsibilities

• Drive successful execution and proactive management of clinical projects.
• Monitor enrollment, retention, and metrics; identify trends and act.
• Identify operational risks; implement mitigation strategies.
• Manage TMF and coordinate audits with QA.
• Proactively manage timelines and budgets; review invoices.
• Lead day-to-day study team activities and trainings.

Skills

Project leadership

Study oversight

Risk management

Quality compliance

Budget mgmt

Team leadership

English fluency

Travel up to 30%

Education

Bachelor's degree in life science

MS/PhD preferred

Tools

Excel

MS Office

Job description

Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

About the Role

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 key point of contact you'll interface directly with sponsors, vendors, cross-functional team members and investigative sites. You'll identify and evaluate risks, interpret data on complex issues and implement solutions to ensure successful completion of oncology trials.

What You'll Do

• Clinical Project Leadership: 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.
• Study Oversight: 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.
• Risk and Quality Management: 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.
• Compliance and Audits: Manage the Trial Master File (TMF) for Clinical Operations documentation and ensure inspection readiness. Collaborate with Quality Assurance for internal and external audits.
• Budget and Timelines: 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.
• Team Management: Lead and manage the day-to-day activities of the study team, including leading team meetings and conducting study-specific training.

What You Need

Education and Experience:

• 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 (minimum 5 years for Sr level), with a track record in successfully managing clinical trial sites
• 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 Sr level project managers)
• Must be fluent in English (verbal and written)
• Ability to travel occasionally up to 30% when required, domestic and/or global
• Valid Driver's License an advantage

What We Offer

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.

This position is not eligible for company provided sponsorship or relocation.

Theradex is an Equal Opportunity Employer.