Senior Local Trial Manager, Immunology
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: Spring House • Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $89,000 - $143,750 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Responsible for local management of a clinical trial in a country or countries.
- Act as the primary point of contact at a country level for assigned studies.
- Operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities.
- Coordinate and lead the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
- Actively contribute to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM), and Associate Local Trial Managers.
- May perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country.
Requirements
- A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field is required.
- Minimum of 2 years of clinical trial management experience or a total of at least 5 years of clinical trial monitoring and/or clinical trial management experience.
- Good understanding of the drug development process including GCP and local regulatory requirements.
- Willingness to travel with occasional overnight stay away from home.
- Minimum of 2 years of leadership experience.
- Computer skills required.
- Proficient in speaking and writing the country language and English language.
- Excellent written and oral communication skills.
- Some experience in mentoring/coaching and providing training to other LTMs, SMs, and CTAs preferred.
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- up to 120 hours of vacation per calendar year
- up to 40 hours of sick time per calendar year
- up to 13 days of holiday pay including floating holidays
- up to 40 hours of work, personal and family time per calendar year
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementclinical trial monitoringGood Clinical Practice (GCP)drug development processregulatory requirementstrainingmentoringcoachingdata quality managementprotocol compliance
Soft skills
leadershipcommunicationteam coordinationprocess improvementwritten communicationoral communicationinterpersonal skillsorganizational skillsproblem-solvingadaptability