Manager, Regulatory

March 29

Care Access

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A new vision for healthcare. Where clinical research is a patient care option.

rare diseases • pulmonology • oncology • decentralized • decentralized trials

201 - 500

Description

• Lead and oversee all aspects of the central regulatory team operations • Manage direct reports including Regulatory Specialist & Regulatory Coordinators • Provide back-up support to Regulatory Associate role as needed • Design creative solutions to stay within regulatory guidelines while the company creates new ways to run clinical trials • Assist in the development and maintenance of KPIs to measure department success • Develop and maintain electronic regulatory platforms • Manage regulatory document/ISF quality through internal review • Maintain knowledge of pertinent regulations and guidance • Ensure quality is maintained in all investigator site files and regulatory workflows • Support the submission of new CLIA waiver applications and maintain CLIA certification for sites or other required Site or PI level regulatory registrations certificates • Constantly strive to improve the department • Lead by example and display a high level of integrity and professionalism

Requirements

• Bachelor’s Degree required in life sciences or equivalent education • A minimum of 3 years of experience managing direct reports and teams • A minimum of 3 years of experience in regulatory • CCRC or CCRP certification preferred

Benefits

• Competitive salary • Health, dental, and vision insurance • 401(k) retirement plan with matching • Paid time off and holidays • Professional development opportunities