• As 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
  • Lead team meetings, teleconference, and face to face 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.

• As a Senior Project Manager 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:
  • Provide oversight and support for all functional areas to ensure superior quality deliverables
  • Identify and evaluate risks, interpret data on complex issues, and implement solutions in order to ensure successful completion of trials.
  • Provide oversight to team members for project specific training
  • Review and provide input to new project proposals/contract development
  • Manage and track project conduct
  • Oversee assigned studies and is accountable for all study resultsReview and provide input to new project proposals/contract developmentManage and track project conduct
  • Generate study specific plans and documents
  • Create trial-related training materials for site initiations and ongoing site training
  • Establish and maintaining study timelines
  • Create/Review study status reports and monitoring reports to identify and address possible issues
  • Lead team meetings, teleconference, and face to face meetings
  • Oversee Trial Master File and/or Electronic Study Files
  • 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 in a medical field required – i.e. 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 6 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.
• Thorough knowledge of the initiation, conduct, and completion of all phases of clinical trials
• Highly organized and result-oriented
• Highly effective ability to anticipate problems relating to projects and to develop and implement solutions
• Highly developed leadership skills
• Excellent interpersonal skills
• Strong communication skills (both written and oral)
• Highly effective ability to set and meet personal short- and long-term 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 knowledge of written and verbal English
• Membership in American Society of Clinical Oncology, preferred