[Hiring] Senior Manager of Research Regulatory Affairs @Sarah Cannon Research Institute

Role Description

The Senior Manager for Research Regulatory Affairs is responsible for the overall operations, which include but are not limited to:

• Overseeing the regulatory start-up and maintenance of trials, including safety and conflict of interest.
• Working closely with research sites, study activation, research protocol operations, budget, and contracts team.
• Developing and implementing regulatory policies and procedures for the sites and the site Clinical Operations team.
• Managing regulatory affairs for multiple clinical trials according to FDA and GCP guidelines.
• Managing relationships between industry partners and the FDA regarding regulatory compliance.
• Problem-solving with department managers and other site leadership as issues arise.
• Assisting in developing and executing internal and external strategies.
• Providing oversight, leadership, and direction in regulatory study startup and maintenance areas.
• Assessing organizational processes associated with regulatory startup to identify improvements.
• Meeting with site leadership to ensure contracted services are provided by the teams.
• Leading people, setting direction, and deploying resources.
• Attracting and selecting talent, supporting onboarding, and driving performance through team members.
• Developing metrics and reports KPI on a weekly and monthly basis.
• Investigating complex customer requests and complaints, developing remediation plans, and leading implementation.
• Providing leadership and direction to employees through other managers or directly.
• Developing and executing functional or departmental strategy to achieve key business objectives.
• Keeping executive and management team informed of issues, progress, and risks related to regulatory affairs.
• Developing, implementing, and evaluating programs to promote recruitment, retention, and continuing education of the team.
• Attending and participating in all required meetings including weekly operational reviews and Director’s meetings.
• Assisting in the development and tracking of department goals and metrics.
• Working closely with monitors, sponsors/CROs, sites, and team to ensure quality and timely work delivery.
• Supporting and collaborating with IRB counterparts to ensure quality relationships.
• Representing company vision to colleagues and external customers.
• Tracking and communicating performance expectations and status to team and sites.
• Working with other members in Research Operations to ensure effective communication and responsibility.
• Adhering to professional standards and SOPs established for clinical research.
• Participating in educational activities and programs.
• Maintaining strictest confidentiality.
• Providing proactive and creative recommendations on meeting corporate and role-specific goals.
• Communicating and escalating unresolved issues appropriately.
• Providing high-level customer service, support, and problem resolution to ensure delivery of organizational goals.

Qualifications

• A Bachelor’s Degree; preferably a Master’s Degree.
• At least three years of research experience either on the site side or within the industry.
• At least three years of management experience with direct reports.
• Research certification (ACRP or CCRP) is preferred.

Benefits

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.

• Competitive compensation package determined by performance, experience, skills, equity, and geographical markets.
• Other compensation such as an annual bonus or long-term incentive opportunities may be offered.