Clinical Trial Manager, Clinical Operations
Madrigal Pharmaceuticals
August 20, 2026
Remote friendly (Conshohocken, PA)
United States
Clinical Research and Development
Clinical Trial Manager
Key Responsibilities:
- Independently lead day-to-day operational management of one or more assigned global clinical trials (Phase I–IV).
- Serve as primary operational lead; ensure milestones, timelines, budgets, quality expectations, and operational deliverables are achieved.
- Lead clinical trial start-up, maintenance, close-out, and inspection readiness activities.
- Develop/review/finalize key study documentation (e.g., study plan, manuals, monitoring plans, ICFs, protocols, protocol amendments, trackers).
- Ensure Trial Master File (TMF/eTMF) is complete, accurate, and inspection-ready.
- Identify operational risks, implement mitigation strategies, and escalate significant issues.
- Oversee CROs/vendors (performance management, issue resolution, deliverable tracking).
- Coordinate investigator/site selection and investigational site activation activities.
- Lead operational study meetings; manage agendas, minutes, and action items.
- Collaborate cross-functionally (Data Management, Clinical Supply, Biometrics, Regulatory, PV, Medical Writing).
- Monitor enrollment/subject tracking/data quality and protocol compliance.
- Support protocol amendments, regulatory submissions, inspections, and audits.
- Participate in UAT for CTMS/eTMF/EDC/IRT.
- Monitor investigator payments, budgets, contracts, PO/invoices.
- Identify operational efficiencies; contribute to SOP/process improvements; mentor junior staff.
Required Qualifications:
- Strong knowledge of clinical trial operations and ICH-GCP.
- Experience independently managing operational aspects of multiple concurrent global trials.
- Working knowledge of FDA/global requirements and inspection readiness.
- Strong project management, organization, communication, and mentoring skills.
- Proficiency with Microsoft Office and clinical systems (CTMS, eTMF, EDC, IRT).
- Bachelor’s degree in Life Sciences/Health Sciences (or equivalent) and 5–7+ years clinical trial operations experience.
Preferred Qualifications:
- Experience identifying operational efficiencies; supporting inspections/audits.
- Experience in biotech/dynamic pharma, early-phase/registrational/global studies.
- Therapeutic experience in metabolic disease/hepatology/cardiovascular.
Benefits/Compensation (as stated):
- Full-time: base pay, bonus, equity, and comprehensive benefits; base salary estimate: $143,007–$168,465/year.
Application Instructions:
- Apply via the Madrigal Careers site; applications accepted on an ongoing basis.
Key Responsibilities:
- Independently lead day-to-day operational management of one or more assigned global clinical trials (Phase I–IV).
- Serve as primary operational lead; ensure milestones, timelines, budgets, quality expectations, and operational deliverables are achieved.
- Lead clinical trial start-up, maintenance, close-out, and inspection readiness activities.
- Develop/review/finalize key study documentation (e.g., study plan, manuals, monitoring plans, ICFs, protocols, protocol amendments, trackers).
- Ensure Trial Master File (TMF/eTMF) is complete, accurate, and inspection-ready.
- Identify operational risks, implement mitigation strategies, and escalate significant issues.
- Oversee CROs/vendors (performance management, issue resolution, deliverable tracking).
- Coordinate investigator/site selection and investigational site activation activities.
- Lead operational study meetings; manage agendas, minutes, and action items.
- Collaborate cross-functionally (Data Management, Clinical Supply, Biometrics, Regulatory, PV, Medical Writing).
- Monitor enrollment/subject tracking/data quality and protocol compliance.
- Support protocol amendments, regulatory submissions, inspections, and audits.
- Participate in UAT for CTMS/eTMF/EDC/IRT.
- Monitor investigator payments, budgets, contracts, PO/invoices.
- Identify operational efficiencies; contribute to SOP/process improvements; mentor junior staff.
Required Qualifications:
- Strong knowledge of clinical trial operations and ICH-GCP.
- Experience independently managing operational aspects of multiple concurrent global trials.
- Working knowledge of FDA/global requirements and inspection readiness.
- Strong project management, organization, communication, and mentoring skills.
- Proficiency with Microsoft Office and clinical systems (CTMS, eTMF, EDC, IRT).
- Bachelor’s degree in Life Sciences/Health Sciences (or equivalent) and 5–7+ years clinical trial operations experience.
Preferred Qualifications:
- Experience identifying operational efficiencies; supporting inspections/audits.
- Experience in biotech/dynamic pharma, early-phase/registrational/global studies.
- Therapeutic experience in metabolic disease/hepatology/cardiovascular.
Benefits/Compensation (as stated):
- Full-time: base pay, bonus, equity, and comprehensive benefits; base salary estimate: $143,007–$168,465/year.
Application Instructions:
- Apply via the Madrigal Careers site; applications accepted on an ongoing basis.