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 - $120,000USDThe 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 - $120,000USDWe 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.
