Senior Manager, Research Regulatory Affairs - Remote US

Sarah Cannon Research Institute

1d • Remote

About The Position

It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. Our Senior Manager, Research Regulatory Affairs is responsible for overseeing all regulatory operations, including but not limited to Regulatory Affairs Specialists, Conflict of Interest processes, Safety, and Process Specialists. This leader will collaborate closely with study activation teams, protocol and research operations, budget and contracts, and finance to continually evaluate and optimize regulatory workflows and performance metrics. The goal is to ensure regulatory activities operate as efficiently as possible and consistently meet or exceed organizational expectations. This role requires experienced managerial and leadership capabilities, along with exceptional customer service skills, enabling effective communication and collaboration with internal stakeholders, pharmaceutical sponsors, CRO partners, IRBs, site research teams, and physicians. This is a fully remote position in the US; relocation assistance and visa sponsorship are not available.

Requirements

• Bachelor's Degree and/or Master's Degree required, experience may be substituted for education
• 5+ years work experience focused in clinical research and regulatory requirements for clinical research
• Work experience should include organizational policies, standard operating procedures, strategic planning skills, and clinical systems
• Expertise in mentoring and coaching teams for success performance including communications, organizational skills, and commitments to individual and team success.

Responsibilities

• Oversees the regulatory start-up and maintenance of trials; including safety and conflict of interest.
• Works closely with our research sites, study activation, research protocol operations, budget, and contracts team.
• Develops and implements regulatory policies and procedures for the sites and the site Clinical Operations teams; including managing and planning regulatory affairs compliance for industry sponsors and/or sites.
• Manages the regulatory affairs between the organization for multiple clinical trials according to FDA and GCP guidelines; for individual sites, studies, sponsors and/or other networks
• Manages the relationships between industry partners and the FDA regarding regulatory compliance for the organization and managing regulatory audits of studies by sponsor/industry and governmental auditors.
• Problem solves with the department managers and other site leadership as they arise.
• Assists in developing and executing the Sarah Cannon internal and external strategies.
• Provides oversight, leadership, and direction in the regulatory study startup of trials and in maintenance areas where support is provided, and other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level