New

Manager, Regulatory Operations

Chicago, IL

Responsible for the oversight and execution of study start-up and maintenance for all assigned projects in accordance with applicable regulatory guidelines/requirements, Tempus Compass Standard Operating Procedures (SOPs), and project specific plans. As an integral member of the study team, will work cross-functionally to execute on the strategy and report on progress related to project timelines and goals to the Sr. Manager, Regulatory Operations. As a manager, may be responsible for oversight of direct reports, or mentoring and coaching colleagues to ensure overall project efficiency.

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 ICHGCP 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.

The expected salary range below is applicable if the role is performed from [New York] and may vary for other locations. 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.

New York Pay Range

$90,000 - $120,000 USD

The expected salary range below is applicable if the role is performed from [Illinois] and may vary for other locations. 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.

Illinois Pay Range

$90,000 - $120,000 USD

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.

 

Additionally, for remote roles open to individuals in unincorporated Los Angeles – including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Tempus’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.