Sr Regulatory Program Manager

Sr. Regulatory Program Manager

Temple University's Lewis Katz School Of Medicine is searching for a Sr. Regulatory Program Manager. Salary Range : $70,000 - $80,000. A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Become a part of the Temple family and you will have access to the following : full medical, dental, vision coverage, paid time off, federally observed paid holidays, personal days, tuition remission, a generous retirement plan, and so much more!

Position Summary

This position is responsible for managing and coordinating regulatory activities related to clinical research studies under the LKSOM, including the preparation and submission of regulatory documents to IRBs, sponsors, and other governing bodies. The role involves supervision and training of regulatory staff, maintaining compliance with institutional and federal regulations, and supporting quality assurance initiatives. The position serves as a primary liaison between investigators, sponsors, and regulatory agencies to ensure smooth study conduct from initiation through closeout. Additionally, the role includes oversight of electronic document management systems, participation in audits and inspections, and active involvement in departmental process improvements and staff education as well as onsite clinical research suite oversight.

Job Details

• This position requires the following background checks : criminal history review Required Education and Experience :
• Bachelor's Degree and 5 years of relevant experience
• An equivalent combination of education and experience may be considered Required Skills and Abilities :
• Prior experience with IRB submissions both local and central
• Prior research experience in a healthcare setting
• Strong leadership, management, and team-building skills.
• Excellent communication and interpersonal skills. Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants.
• Ability to operate all standard office equipment / software including MS office.
• Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines.

Essential Duties

Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status.