Senior Clinical Trial Manager
New
U
Umoja BiopharmaBiotechnology
Remote work within the USFull-TimeSenior
Salary125,000 - 175,000 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- 6+ years for Manager; 8+ years for Senior Manager
- Required Skills
- Budget management
Requirements
- Bachelor’s degree or equivalent in Life Sciences.
- At least 6 years (Manager) or 8 years (Senior Manager) of clinical operations experience in the pharmaceutical industry.
- Minimum 1-3 years experience managing industry-sponsored clinical studies as a sponsor employee.
- Significant knowledge of GCP/ICH guidelines and the clinical development process.
- Experience managing CROs and other vendors and assessing performance.
- Experience leading, managing, or mentoring clinical operational staff and cross-functional teams.
- Demonstrated ability to work independently and as part of a multi-functional team.
- Strong organizational and problem-solving skills with the ability to balance changing priorities.
- Ability to travel as needed (approximately 20%).
- Experience supporting Phase 1 and 2 clinical trials is preferred.
- Oncology experience is highly preferred.
Responsibilities
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines.
- Independently develop study timelines, key deliverables, and risk/mitigation strategies.
- Lead selection and performance management of CROs and other ancillary vendors.
- Plan and lead study team meetings.
- Lead the development of study materials including monitoring guidelines, site initiation materials, and study tools.
- Contribute to the content and review of study documents like protocols, informed consent forms, and CRFs.
- Track and ensure optimization of site startup, subject enrollment, data collection, and trial closeout.
- Negotiate and manage budgets and payments for clinical sites.
- Oversee the Trial Master File (TMF) and ensure accurate execution of site monitoring reports.
View Full Description & ApplyYou'll be redirected to the employer's site
