Clinical Operations Manager, AACR Center for Cancer Clinical Trials - Philadelphia - ref. q52160515

Overview:

Organizational Profile:

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 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.

10% travel).

Responsibilities:

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:

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.