Celebrating 40+ years!

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.

Key Responsibilities

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

Project Manager of the NCI CTMS is responsible for operational aspects of the CTMS monitoring and auditing, which includes but is not limited to:

• • Provide oversight of NCI CTMS Clinical Research Associates (i.e., monitors) from an operational perspective and lead team meetings
  • Select patient cases for all CTMS ETCTN monitoring visits
  • Review all NCI CTMS site visit reports
  • Review all corrective and preventive action plans provided by cancer centers in response to CTMS data audits, annual and cancer center site visits.
  • Lead the conduct and reporting of selected NCI CTMS audits in accordance with NCI Experimental Therapeutics Clinical Trial Network (ETCTN) guidelines
  • Maintain and continuously analyze cancer center performance metrics for discussion with NCI Clinical Trials Monitoring Branch (CTMB) leadership.
  • Write the monitoring and site performance content of NCI CTMS semi-annual progress reports and other reports as required.
  • Review of the eligibility criteria for new EDC study builds.
  • Provide administrative support to the NCI ETCTN Data and Safety Monitoring Board (DSMB) through collaboration with CTMB, development and review of DSMB operating procedures and charter, follow the progress of all studies overseen by the DSMB, alert internal and external stakeholders of anticipated meetings, work with Theradex Oncology statistical programming and data management in preparation of meetings, prepare status reports for DSMB members, organize and deliver training on DSMB procedures to study investigators and study statisticians, prepare DSMB meeting minutes and follow up letters.

Senior Project Manager, this role is responsible for leading both technical and operational aspects of each project to ensure compliance with FDA regulations and Theradex procedures.  Other responsibilities include but are not limited to:

• • Oversee all functional areas to ensure high-quality deliverables and lead team meetings
  • Identify risks and complex issues, interpret data, and implement solutions to complete trials successfully
  • Provide oversight to team members for project specific training
  • Review and provide feedback on new project proposals and contracts
  • Manage and track project conduct
  • Oversee assigned studies and is accountable for all study results
  • Manage and track project progress
  • Generate study specific plans and documents
  • Create trial-related training materials for site initiations and ongoing site training
  • Establish and maintain study timelines
  • Create and review study and monitoring reports to identify and address issues
  • Oversee Trial Master File and/or Electronic Study Files
  • Supervision of Investigational Product Storage and Distribution Team (remote)
  • Assume other project responsibilities as needed

Provide clinical research expertise to Theradex Board of Directors by attendance and contribution to bid defense meetings and other sponsor-specific meetings as required.

Level of Education

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

Prior Experience

• 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

Skills and Competencies

• 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

Additional Requirements

• 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

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 $180,000 - $220,000. 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 relocation or company provided sponsorship.

Theradex is an Equal Opportunity Employer.