Principal Regulatory Affairs Specialist
Medtronic
Cyber SecurityPMPSDLC
Manager, Regulatory Operations
Tempus AI
full-time
Posted on:
Location Type: Hybrid
Location: Chicago • California, Illinois, New York • 🇺🇸 United States
Visit company websiteSalary
💰 $90,000 - $120,000 per year
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Efficiently manages and successfully executes all aspects of study start-up and maintenance.
- Supports Sr. Associate as needed with ongoing regular outreach to clinical sites.
- 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.
- 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 in preparation for internal and client calls.
- Provides oversight for all activities assigned to Associate/Sr. Associate.
- 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.
Requirements
- 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.
- Prior experience in team or line management (preferred).
- Experience tracking in a CTMS or online database (preferred).
Benefits
- incentive compensation
- restricted stock units
- medical and other benefits depending on the position
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical research experiencestudy start-upfeasibility trackingstudy file reviewssubmission of documentscontract negotiationsbudget negotiationspeople managementperformance appraisalstraining
Soft skills
presentation skillsnegotiation skillsdocumentation skillsleadership skillsteam orientationinterpersonal skillswritten communicationoral communicationorganizational skillscustomer focus
Certifications
university/college degreecertification in allied health profession
