Project Lead, NCI Clinical Trials Monitoring Service

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.

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

We are seeking an oncology research professional with 6+ years experience within an academic clinical oncology, pharmaceutical industry, or CRO environment. To be considered you must hold either a PharmD or Doctor of Medicine (MD) from an accredited institution. Experience with clinical trials sponsored by the NCI is preferred. 

In this role, you'll serve as Project Manager of the National Cancer Institute Clinical Trials Monitoring Service, overseeing cancer center audit visits, and serve as Project Manager of the NCI Experimental Therapeutics Clinical Trial Network (ETCTN). You'll be the primary contact for the NCI Clinical Trials Monitoring Branch, NCI members, interacting with principal investigators, study statisticians, sponsors, medical monitors, vendors, auditors, and site representatives.

The primary responsibilities of this position include, but are not limited to, the following:

• →Advanced Degree either Pharm.D. or M.D. degree required.

• Minimum 6 years academic oncology/pharmaceutical industry/CRO experience, in positions of increasing responsibility, is required.
• Minimum 6 years of oncology experience is required.
• Minimum 4 years of leadership/management experience is required.
• Academic clinical oncology research experience required. Experience with trials sponsored by the NCI is preferred.
• Prior project management experience with demonstrated leadership skills in a CRO/pharmaceutical environment is preferred

• Thorough knowledge of current Federal regulations and applicable guidelines and guidance, particularly those dealing with National Cancer Institute study monitoring and good clinical practice.
• Understanding of clinical trial phases from initiation through completion
• Highly organized and result-oriented
• Ability to anticipate project problems and develop solutions
• Strong leadership skills
• Excellent interpersonal skills
• Strong communication skills (both written and verbal)
• Ability to set and achieve goals 
• Ability to work independently as well as in a team environment
• Proficient knowledge of Word, Excel and PowerPoint

• Ability to travel – up to 20% travel required, primarily in the U.S. and Canada
• Valid Driver’s License
• Fluent in written and spoken English
• Membership in American Society of Clinical Oncology, preferred