Project Lead, NCI Clinical Trials Monitoring Service

Theradex Oncology•Princeton, NJ

10d•$180,000 - $220,000•Onsite

About The Position

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.

Requirements

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.
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

Nice To Haves

Experience with clinical trials sponsored by the NCI is preferred.
Prior project management experience with demonstrated leadership skills in a CRO/pharmaceutical environment is preferred
Membership in American Society of Clinical Oncology, preferred

Responsibilities

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.
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.