Manager, Regulatory Operations

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

Job Responsibilities

• Efficiently manages and successfully executes all aspects of study start-up and maintenance which includes but is not limited to initial site outreach to begin the CDA process, feasibility, regulatory packet creation and dissemination to selected sites, site outreach involving relationship building and helping to ensure study timelines are met, etc.

• Supports Sr. Associate as needed with ongoing regular outreach to clinical sites to facilitate essential document collection and other start up and maintenance related 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) to ensure compliance with ICH-GCP requirements and completes necessary documentation.

• Reviews Central IRB or site-adapted ICFs for compliance with protocol elements and ICH-GCP requirements and completes necessary documentation. Provides site-specific ICFs to Sponsor for review as required per study plans.

• Completes submission of necessary documents to the Central IRB.

• May support Contract and Budget negotiations with sites and liaising with the sponsor.

• Reviews pertinent regulations to develop proactive solutions to start-up issues and challenges.

• Provides regular updates/reports to the study team in preparation for internal and client calls.

• Presents status updates as necessary in project-related meetings/teleconferences per the study team.

• Provides oversight for all 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 as necessary.

• May be responsible for people management activities including interviewing, professional development, performance appraisals, training, and mentorship.

• Performs other duties as assigned.

• May involve travel.

Demonstration of Tempus Compass Values

Consistently strives to demonstrate the following Tempus Compass values:

• Recognizes that the team is always stronger than the individual.

• Seeks to inspire others by demonstrating consistently strong performance.

• Treats people with respect regardless of role or point of view.

• Listens well and seek to understand before reacting.

• Provides candid, helpful and timely feedback to colleagues.

• Demonstrates curiosity about and contributes effectively to areas outside of their specialty.

• Keeps the bigger picture in mind when making decisions.

• Never stops learning.

• Questions assumptions and offers suggestions for improvement.

• Focuses on results rather than process and seeks to minimize complexity when process is required.

• Identifies and addresses root causes, not symptoms.

• Demonstrates poise in stressful situations.

• Strives to always do the right thing.

• Questions actions that are incongruent with Tempus Compass values.

Minimum Qualifications

• University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing) from an appropriately accredited institution.

• 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, as well as 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 and remain flexible and adaptive in stressful situations.

Preferred Qualifications

• Prior experience in team or line management.

• Experience tracking in a CTMS or online database.

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Pay Range: $90,000-$120,000

The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.