Sr. Manager of Research Regulatory Affairs

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. The Senior Manager for Research Regulatory Affairs is responsible for the overall operations of, which include but is not limited to Regulatory Affairs Specialist, Conflict of Interest, Safety, Process Specialist. This individual will also work very closely with study activation site research teams, protocol research operations, budget, and contract department, and finance to continue evaluating our regulatory processes and metrics to ensure regulatory is working as efficiently as possible to meet or exceed our goals. In this role, the individual must have managerial and leadership skills as well great customer service skills to comfortably interact and communicate with internal teams, pharma/CRO teams, IRBs, site research teams and our physicians. The Senior Manager: 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 team; 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 Assesses organizational processes associated with regulatory startup and support to identify ways to improve and streamline processes   Meets with site leadership as needed to ensure contracted services are being provided by the teams Accountable for leading people, setting direction, and deploying resources; responsible for attracting and selecting talent; support onboarding new employees to decrease time to productivity; driving performance through their team members by setting direction, providing feedback, and creating a trust-based, inclusive work environment; developing employees through coaching and feedback; rewarding and recognizing employees via ongoing recognition and core pay-for-performance practices are primarily achieved through the work of others and typically depend on the manager's ability to influence and negotiate with parts of the organization where formal authority is not held. Develops metrics and reports KPI on weekly and monthly basis to department managers to ensure targets initiatives are being met. Investigates complex and unusual customer requests and complaints, develops remediation plan and leads implementation. Provides leadership and direction to employees either through other managers or directly to employees. Develops, adapts, and executes functional or departmental strategy to achieve key business objectives in area of responsibility. Keeps executive and management team abreast of issues, progress, and risks related to regulatory affairs Develops, implements, and evaluates programs to promote recruitment, retention, and continuing education of the team Attends and participates in all required meetings including weekly operational review and Director’s meeting Assists in development and tracking of department goals and metrics Works closely with monitors, sponsors/CROs, sites, and team to ensure quality and timely work being delivered   Support and collaborate with IRB counterparts to ensure quality relationships Represents company vision to colleagues and external customers Tracks and communicates to team and sites performance expectations and status Works with other members in Research Operations to ensure communication and responsibility are effective and appropriate Adhere to professional standards and SOPs established for clinical research and develop newSOPs and or Working Practice Guidelines as appropriate. Monitor adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. Participate in educational activities and programs Maintain strictest confidentiality Provide proactive and creative recommendations on how to meet corporate and role-specific goals and handle identified deviations Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management Provide high level customer service, support and problem resolution to ensure the delivery of organizational goals You should have for this position: A Bachelor’s Degree preferably a Master’s De