Clinical Trial Manager, Clinical Operations

Madrigal Pharmaceuticals•Conshohocken, PA

3d•$143,007 - $168,465

About The Position

The Clinical Trial Manager is an experienced clinical operations professional responsible for independently leading the operational execution of global clinical trials within a rapidly growing biotechnology company. The Clinical Trial Manager partners closely with other members within Clinical Operations, cross-functional functional areas, CROs, vendors, and investigational sites to drive successful study execution across multiple phases of clinical development. This role independently manages one or more clinical studies or major study components, ensuring operational excellence throughout the study lifecycle. The Clinical Trial Manager provides oversight of study timelines, vendor performance, budgets, Trial Master File quality, and inspection readiness while proactively identifying and mitigating operational risks. The role serves as the primary operational lead for assigned studies, mentors Associate Clinical Trial Managers and Clinical Trial Specialists, and contributes to process improvements that enhance operational efficiency while ensuring compliance with ICH-GCP, applicable regulatory requirements, and company SOPs.

Requirements

Strong knowledge of clinical trial operations across all phases of development and comprehensive understanding of ICH-GCP guidelines.
Demonstrated experience independently managing operational aspects of multiple concurrent global clinical trials.
Experience providing operational leadership for assigned studies while collaborating effectively with CROs, vendors, investigational sites, and cross-functional teams.
Working knowledge of FDA regulations, global clinical trial requirements, and inspection readiness activities.
Demonstrated ability to proactively identify operational risks, implement mitigation strategies, and drive issue resolution.
Strong project management skills with the ability to prioritize competing demands while managing multiple studies simultaneously.
Excellent organizational skills with exceptional attention to detail.
Strong interpersonal, written, verbal, and presentation skills with the ability to effectively influence cross-functional teams.
Demonstrated ability to mentor junior Clinical Operations professionals and foster collaborative working relationships.
Proficiency with Microsoft Office Suite and clinical systems including CTMS, eTMF, EDC, IRT, and related clinical technology platforms.
Bachelor's degree in Life Sciences, Health Sciences, or a related discipline, or equivalent combination of education and relevant experience.
Minimum of 5–7 years of progressive clinical trial operations experience within biotechnology or pharmaceutical industry settings.
Demonstrated experience independently managing Phase I–IV clinical studies and collaborating effectively with CROs and cross-functional teams.

Nice To Haves

Experience identifying operational efficiencies and implementing process improvements preferred.
Experience supporting regulatory inspections, GCP audits, and inspection readiness activities preferred.
Experience in biotechnology or other dynamic pharmaceutical environments preferred.
Experience supporting early-phase, registrational, or global clinical studies preferred.
Therapeutic experience in metabolic disease, hepatology, cardiovascular disease, or related therapeutic areas preferred.

Responsibilities

Independently lead day-to-day operational management of one or more assigned global clinical trials (Phase I–IV).
Serve as the primary operational lead for assigned studies, ensuring study milestones, timelines, budgets, quality expectations, and operational deliverables are achieved.
Lead and coordinate clinical trial start-up, maintenance, close-out, and inspection readiness activities with minimal supervision.
Develop, review, and finalize key study documentation including study plans, operational manuals, monitoring plans, newsletters, trackers, informed consent forms (ICFs), protocols, protocol amendments, and other operational documents.
Ensure the Trial Master File (TMF/eTMF) is complete, accurate, and inspection-ready throughout the study lifecycle.
Proactively identify study risks and operational challenges while implementing appropriate mitigation strategies and escalating significant issues to Clinical Operations leadership when appropriate.
Lead operational oversight of CROs and vendors, including performance management, issue resolution, deliverable tracking, and ongoing relationship management.
Coordinate investigator and site selection activities in collaboration with Clinical Operations leadership and CRO partners.
Support and oversee investigational site activation activities, including review of regulatory documentation and essential study documents.
Lead operational study meetings, prepare meeting agendas and minutes, and ensure action items are completed within established timelines.
Collaborate with Data Management, Clinical Supply, Biometrics, Regulatory Affairs, Pharmacovigilance, Medical Writing, and other cross-functional teams to support successful study execution.
Monitor study enrollment, subject tracking, data quality metrics, and overall study progress while ensuring protocol compliance.
Support protocol amendments, regulatory submissions, health authority inspections, and internal and external audits.
Participate in User Acceptance Testing (UAT) activities for CTMS, eTMF, EDC, IRT, and other clinical systems.
Monitor investigator payments, study budgets, contracts, purchase orders, and vendor invoices while ensuring financial accountability.
Contribute to CRO selection, vendor onboarding, oversight, and performance management activities.
Identify opportunities for operational efficiencies and contribute to the development and refinement of Clinical Operations SOPs, work instructions, templates, and best practices.
Mentor Associate Clinical Trial Managers, Clinical Trial Specialists, and other Clinical Operations personnel, as appropriate.
Perform additional responsibilities as assigned.