Clinical Operations Manager, AACR Center for Cancer Clinical Trials - American Association for Cancer Research

Organizational Profile:

Founded in 1907, the American Association for Cancer Research (AACR) is the world’s first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR membership includes more than 59,000 laboratory, translational, and clinical researchers; population scientists; other health care professionals; and patient advocates residing in 143 countries and territories around the world. The AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, diagnosis, and treatment of cancer by annually convening more than 30 conferences and educational workshops including the AACR Annual Meeting. It publishes ten scientific journals, a magazine for cancer survivors, patients, and their caregivers, and funds meritorious research directly and in cooperation with numerous cancer organizations. As the scientific partner of Stand Up To Cancer, the AACR provides expert peer review, grants administration, and scientific oversight of team science and individual investigator grants. In addition, the AACR actively communicates with legislators and other policymakers about the value of cancer research. Through its collective programs and services, the AACR fosters research in cancer and related biomedical science in support of its mission to prevent and cure cancer.

Position Summary:

The AACR seeks an experienced and results-driven professional interested in improving patient outcomes and advancing science through collaborative approaches to clinical trials. Leveraging their experience in operationalizing clinical research, they will be an integral part of the team overseeing all study-related activities of the newly formed AACR Center for Clinical Trials. The manager will assist the center’s director in managing day-to-day operations and the planning, implementation, management, and execution of AACR-sponsored studies. Working with internal and external stakeholders including pharmaceutical partners, clinical sites, patient advocacy organizations, and vendors, they will be responsible for leading operational management, assisting with financial and contractual oversight, and ensuring ongoing adherence to human subject regulations and policies of Good Clinical Practice. The successful candidate will serve as a pivotal staff member helping to operationalize the AACR Center for Cancer Clinical Trials’ complex projects.  They will travel locally and nationally on an as needed basis to sites, vendors, partners, and/or to attend relevant meetings (est. 10% travel).

Major Duties and Responsibilities:

• Assist with day-to-day operations of the AACR Center for Clinical Trials to ensure operational excellence and safe and effective execution of AACR-sponsored studies through all stages including design, start-up, execution, close out, and publication.
• Assist with the oversight and management of various vendor and partner relationships including CROs, diagnostic and clinical service providers, and pharmaceutical companies.
• Help to facilitate the work of investigators to develop study protocols, consent forms, reports, and other study documents by scheduling meetings, maintaining documents, and managing timelines.
• Assist with managing communications with clinical trial sites and investigators.
• Assist with AACR fiscal management, invoicing, and reporting.
• Assist with managing various internal and external stakeholder groups (e.g. trial steering committees, the AACR Clinical Trials Advisory Council, the Cancer Centers Alliance Clinical Trials Subcommittee, Data Safety and Monitoring Committees, etc.) by planning and facilitating meetings, developing meeting materials, and preparing reports.
• Assist with the development and management of AACR SOPs and policies.
• Maintain detailed project timelines and helps to ensure that performance milestones are met.
• Proactively work to identify risks, potential issues, and recommend solutions or corrective actions as needed.
• Form productive and collegial relationships with various AACR divisions and departments in support of shared priorities.
• Work with the AACR Foundation staff to cultivate partner relationships and help identify opportunities.
• Perform the essential functions of the position and other tasks as may be assigned and required.

Qualifications:

• Five or more years of experience in clinical research operations in a CRO, pharmaceutical/ biotech, academic, or related environment.
• Prior experience in oncology clinical trials.
• Non-profit sector experience preferred.
• Knowledge of ICH-GCP guidelines and comfort managing medical data.
• Thorough conceptual understanding of the drug development and commercialization process.
• Excellent interpersonal and organizational skills with demonstrated attention to detail.
• Ability to effectively manage complex projects in a deadline-driven environment while maintaining robust relationships with internal and external stakeholders.
• Experience working with contracts preferred.
• Excellent verbal and written communication skills.
• Outstanding computer literacy with proficiency in MS Office.

Education Requirements:

• Bachelor’s or equivalent degree in a scientific or health-related discipline required.
• Master’s degree preferred.
• Relevant professional certification(s) a plus.