New Haven, Connecticut
Category: Scientific & Clinical
Compensation Range: 95000.00 - 110000.00
Job ID: 295896
Date Posted: 03/22/2023
Title: Regulatory Manager
Schedule: Mon-Fri, 8:30am-5pm EST
Type: Direct Hire
Start date: ASAP
Reporting to the Assistant Director for Regulatory Affairs, the Regulatory Affairs Manager is responsible for managing Oncology Disease Group regulatory affairs teams and ensures appropriate infrastructure to support clinical trials regulatory requirements in accordance with the IRB approved study protocol and applicable policies and regulations. This position requires a strong emphasis on people management, including staff recruitment, retention, and performance management to ensure quality, accountability, and growth. Works within a multidisciplinary environment with colleagues both internally and externally in a cooperative manner exercising respectfulness and professionalism.
- Manages and monitors policies, practices, and procedures of Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1 responsible for the management of study portfolios and the execution of regulatory activities for all types of clinical research studies across the lifecycle of the protocol from activation to closeout according to Good Clinical Practice guidelines and applicable federal regulations.
- Responsible for recruiting, hiring, training plans, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the regulatory affairs professionals (Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1
- Assigns and manages workload and provides estimates for individual project staffing needs. Tracks data and metrics to determine appropriate personnel resource allocation based on study parameters. Collaborates with CTO Clinical Research Managers, Project Managers and Principal Investigator (PI) on assessment of highly complex trials clinical research protocols including feasibility, resolving potential discrepancies and/or barriers to enrollment prior to study activation and patient enrollment process.
- Collaborates with CTO Assistant Director for Regulatory Affairs to oversee preparation for regulatory agency and sponsor audits and inspections. Ensures infrastructure to support requirements for clinical trials by evaluating the regulatory, technological, and staff resources required to ensure each clinical trial can be supported in accordance with the study protocol, applicable policies, and regulations. Includes assigning regulatory affairs staff (Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1
- Collaborates with CTO leadership to develop annual measurable goals and objectives for the CTO; measures progress against those goals to report to Assistant Director for Regulatory Affairs. Collaborates with CTO Assistant Director for Regulatory Affairs and Quality and Education unit to determine the best approach for utilizing technology solutions to support clinical research regulatory processes.
- Partners with the CTO Quality and Education unit to ensure proper education and training of regulatory affairs professionals (Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists 2 and Regulatory Affairs Specialists 1 as it pertains to regulatory responsibilities. In partnership with the CTO Quality and Education unit, develops, implements, and evolves Oncology specific role-based curriculum for new employees.
- Participates in performance improvement activities by contributing ideas, experience, and expertise to promote efficiency and quality outcomes for the institution and the department. Continually identifies opportunities for improvement or enhancement in regulatory processes based on experience and information acquired from other programs, professional associations, review publications and conferences.
- Provides a lead role in developing and coordinating departmental policies and procedures to ensure the efficient regulatory operation of clinical trials. Stays abreast of federal and state regulations and local policies. Maintains a high degree of knowledge on these requirements, assesses impact of changes to regulations and policies, and follows directives that may be required to ensure compliance with congruency review and reporting requirements.
- Develops, implements, and champions internal practices that ensure compliance with federal requirements. Identifies, facilitates, and coordinates with the Quality and Education team quality improvement activities including conducting internal quality reviews, analyzing results, and identifying trends that would indicate educational needs. Other duties as assigned.
- Master's degree in a health-related discipline, or other related field. Experience with oncology clinical trials strongly preferred.
- ACRP/SOCRA (or equivalent) certification preferred. Willingness to obtain within one year preferred
- Bachelor’s degree in a health-related discipline and a minimum of seven (7) years of clinical research experience or the equivalent combination of education or experience. Five (5) years of regulatory affairs experience required. Three (3) years of supervisory experience required.
- Expert ability to lead, organize, and execute on complex projects; multi-task, identify, analyze, and resolve problems efficiently and effectively; use independent good judgment and to assess risk. Independently follow through on tasks, develop and execute work plans, prioritize work, and manage multiple assignments to meet deadlines
- Demonstrated ability to ensure appropriate infrastructure by evaluating the regulatory, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the protocol, applicable policies, and regulations. Ability to report on the status of project deliverables and draft and submit project updates to the team and study sponsor
- Strong knowledge of Good Clinical Practice guidelines. Proven experience interpreting federal, state, and sponsor policies and regulations. Experience with interpreting complex oncology clinical trial protocols and federal, state, local guidelines
- Demonstrated ability to provide proactive, flexible, and customer service focused advice; work effectively with others; and demonstrate ethics and integrity in a professional manner, sensitivity to confidentiality, and a commitment to protecting research participants.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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