Clinical Project Manager - Home Based
If you have a minimum of 3-4 years proven experience leading oncology clinical trials and want an opportunity to continue your career within oncology, we want to hear from you.
As a primary point of contact, our project managers are hands-on and interface directly with our sponsors and vendors and cross-functional team members. Our project managers oversee global phase I – III clinical trials startup through closeout to ensure processes, timelines, contracts, ICH/GCP adherence and quality standards are met. They identify and evaluate risks, interpret data on complex issues and implement solutions in order to ensure successful completion of trials.
What’s in it for you? Theradex supports many of the most prominent pharmaceutical and biotech companies in the industry with promising new molecules addressing a wide range of oncology indications. We provide a supportive environment and through our expertise, innovative systems and processes and we give you the tools to be successful as we grow our Clinical Operations Team.
What you need:
- Bachelor’s or Master’s degree in a biological science; e.g. RN with a 4-year degree, PharmD, PhD or equivalent
- PMP Certification preferred
- 3-4 years of experience overseeing project management of clinical trials in a CRO or pharmaceutical environment. CRO experience highly preferred
- Proven experience with the following:
- Managing/leading oncology Phase I and II oncology clinical trials
- Managing/leading Phase III/IV clinical studies
- Start-up and maintenance of Phase I, II & III clinical trials. Closeout experience is preferred
- Managing budgets of study protocols
- Current or previous direct interaction with sponsors/vendors
- Thorough understanding of CRA activities and responsibilities
- The ability to build relationships, communicate effectively (both written and oral) and demonstrate strong interpersonal and motivational skills
- The ability to Identify and evaluate risks, interpret data on complex issues, and implement solutions to ensure successful completion of trials
- Thorough knowledge of current Federal regulations and any applicable guidelines
- Highly knowledgeable in all appropriate project-specific areas, including aspects of the research as specified by contract
- Highly developed leadership, computer, and problem-solving skills
- Ability to travel when needed up to !5% (dependent upon sponsor/study requirements)
What you’ll do:
- Manage and track clinical project/s:
- Generate study specific plans and documents
- Assist in creation of trial related training materials
- Site management- startup, staff training, study conduct maintenance and coordination, site closeout
- Vendor management
- Establish and maintain clinical project timelines including: Study startup activities, patient accrual timelines, data cleaning activities and support, study close-out activities
- Provide oversight and support for all functional areas, ensure assigned studies/programs are delivered successfully, on-time, within budget, according to client expectations and with superior quality deliverables
- Create/Review study status reports and site monitoring reports to identify and address possible issues regarding protocol deviations/compliance, need for site training and monitor drug supply.
- Prepare agendas, minutes and lead team meetings, sponsor/site teleconferences, and face to face meetings for training, safety review and to address sponsor requests.
- Provide input to new clinical project proposals/contract development and participate in scheduled reviews of project budget status and deliverable timelines.
- Ensure adherence to responsibilities assigned to Theradex by sponsor contract
- Direct technical and operational aspects of each project to ensure compliance with FDA regulations and Theradex procedures.
- Oversee Trial Master File and/or Electronic Study Files.
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, 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.