Manager, Regulatory Operations

Tempus • Boca Raton, FL

69d • $90,000 - $120,000 • Hybrid

About The Position

Tempus is seeking a passionate individual to join our team and contribute to advancing the healthcare industry through precision medicine. Our proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, ensuring the right treatments are provided to the right patients at the right time. The role involves managing and executing all aspects of study start-up and maintenance, supporting clinical operations, and ensuring compliance with regulatory requirements.

Requirements

• University/college degree (life science preferred) or certification in a related allied health profession.
• 5 or more years of clinical research experience with study start-up experience within a contract research organization or pharmaceutical company.
• Working knowledge of ICH-GCP.
• Excellent presentation, negotiation, documentation, and leadership skills.
• Strong team-orientation and interpersonal skills.
• Excellent written/oral communication and organization skills.
• Proficient in Microsoft Word and Excel.
• Customer focus with ability to manage challenging priorities.

Nice To Haves

• Prior experience in team or line management.
• Experience tracking in a CTMS or online database.

Responsibilities

• Efficiently manages and successfully executes all aspects of study start-up and maintenance.
• Supports Sr. Associate with ongoing outreach to clinical sites for document collection and study maintenance activities.
• Maintains feasibility tracking through site selection and status tracking in CTMS.
• Performs study file reviews as assigned per the study specific Trial Master File (TMF) plan.
• Reviews master informed consent forms (ICF) for compliance with ICH-GCP requirements.
• Completes submission of necessary documents to the Central IRB.
• May support Contract and Budget negotiations with sites and liaising with the sponsor.
• Provides regular updates/reports to the study team for internal and client calls.
• Presents status updates in project-related meetings/teleconferences.
• Provides oversight for activities assigned to Associate/Sr. Associate.
• Maintains close communication with the study team.
• Works cross-functionally to support RAIS, Clinical Operations, and Project Management departments.
• May be responsible for people management activities including interviewing, professional development, performance appraisals, training, and mentorship.
• Performs other duties as assigned.
• May involve travel.

Benefits

• Incentive compensation
• Restricted stock units
• Medical benefits
• Other benefits depending on the position

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees