Clinical Trial Manager
4D Molecular Therapeutics
July 01, 2026
Remote friendly (United States)
United States
Clinical Research and Development
GENERAL SUMMARY
- Manage day-to-day operations for one or more Phase 1–3 clinical trials, including start-up, conduct, and close-out (may support unmasked activities).
MAJOR DUTIES & RESPONSIBILITIES
- Serve as primary unmasked contact for protocol execution; oversee unmasked CRO, service providers, and consultants.
- Serve as primary sponsor-side unmasked contact for investigative site personnel.
- Support unmasked drug supply/accountability, including IWRS oversight; liaison between Clinical Operations and Clinical Supply.
- Establish study milestones; track and report metrics/timelines to leadership.
- Ensure trials are executed per ICH GCP, regulations, protocol, and company SOPs.
- Support/prepare key trial documents (protocol, informed consent, Investigator Brochure, monitoring plan, project plan, CRFs, SAP, clinical study reports, and other study documents).
- Set up and maintain unmasked Trial Master File (TMF), including periodic reviews.
- Coordinate resolution of audit findings; maintain audit-ready clinical documentation.
- Identify project issues and support resolution/process improvements.
- Conduct unmasked, study-specific training for CRO staff, monitors, sites, and service providers.
- Perform and manage IP data review; oversee outsourced monitoring via unmasked monitoring reports.
- Track/review protocol deviations and assess impact on data.
- Develop/manage study budget and approve clinical invoices; oversee clinical supply forecasting.
QUALIFICATIONS
- B.A./B.S.
- 6+ years biotech/similar clinical research; at least 2 years directly supporting clinical trial management.
SKILLS
- GCP/ICH and regulatory knowledge; strong clinical study management.
- Experience with HCP/payer/advocacy regulatory framework.
- Trial planning (site monitoring strategy, risk mitigation, budget, site selection, clinical supplies).
- Excellent communication, organization, negotiation, conflict resolution, and judgment; creative problem-solving.
- Proficient MS Office; working knowledge of MS Project.
TRAVEL
- 5%.
COMPENSATION
- Base salary range: $150,000–$170,000.
- Manage day-to-day operations for one or more Phase 1–3 clinical trials, including start-up, conduct, and close-out (may support unmasked activities).
MAJOR DUTIES & RESPONSIBILITIES
- Serve as primary unmasked contact for protocol execution; oversee unmasked CRO, service providers, and consultants.
- Serve as primary sponsor-side unmasked contact for investigative site personnel.
- Support unmasked drug supply/accountability, including IWRS oversight; liaison between Clinical Operations and Clinical Supply.
- Establish study milestones; track and report metrics/timelines to leadership.
- Ensure trials are executed per ICH GCP, regulations, protocol, and company SOPs.
- Support/prepare key trial documents (protocol, informed consent, Investigator Brochure, monitoring plan, project plan, CRFs, SAP, clinical study reports, and other study documents).
- Set up and maintain unmasked Trial Master File (TMF), including periodic reviews.
- Coordinate resolution of audit findings; maintain audit-ready clinical documentation.
- Identify project issues and support resolution/process improvements.
- Conduct unmasked, study-specific training for CRO staff, monitors, sites, and service providers.
- Perform and manage IP data review; oversee outsourced monitoring via unmasked monitoring reports.
- Track/review protocol deviations and assess impact on data.
- Develop/manage study budget and approve clinical invoices; oversee clinical supply forecasting.
QUALIFICATIONS
- B.A./B.S.
- 6+ years biotech/similar clinical research; at least 2 years directly supporting clinical trial management.
SKILLS
- GCP/ICH and regulatory knowledge; strong clinical study management.
- Experience with HCP/payer/advocacy regulatory framework.
- Trial planning (site monitoring strategy, risk mitigation, budget, site selection, clinical supplies).
- Excellent communication, organization, negotiation, conflict resolution, and judgment; creative problem-solving.
- Proficient MS Office; working knowledge of MS Project.
TRAVEL
- 5%.
COMPENSATION
- Base salary range: $150,000–$170,000.