Project Lead, NCI Clinical Trials Monitoring Service

Key Responsibilities

• Provide oversight of NCI CTMS Clinical Research Associates (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 ETCTN guidelines
• Maintain and continuously analyze cancer center performance metrics for discussion with NCI CTMB leadership
• Write the monitoring and site performance content of NCI CTMS semi-annual progress reports and other reports as required
• Review 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 progress of all studies overseen by the DSMB, alert internal and external stakeholders of anticipated meetings, work with 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
• Lead both technical and operational aspects of each project to ensure compliance with FDA regulations and Theradex procedures
• 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)
• Provide clinical research expertise to Theradex Board of Directors by attendance and contribution to bid defense meetings and other sponsor-specific meetings as required

What You Need

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.

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