Sr. Manager of Research Regulatory Affairs

Sarah Cannon Research Institute•Work at Home - Tennessee, USA (WTNA), TN

About The Position

The Senior Manager for Research Regulatory Affairs is responsible for the overall operations of, which include but are 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.

Requirements

A Bachelor’s Degree preferably a Master’s Degree
At least three years of Research experience either on the site side or within industry
At least three years of Management with direct reports

Nice To Haves

Research certification (ACRP or CCRP) is preferred

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 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