Global Clinical Trial Manager – Operations Leader

Madrigal Pharmaceuticals, Inc.; Conshohocken (Montgomery County); On-site; USD 143,007 - 168,465; Full time

Benefits offered by this job

Equity

Comprehensive benefits

401(k)

Job summary

Madrigal Pharmaceuticals, Inc. is seeking a Clinical Trial Manager to independently lead global trials across phases I–IV in a fast-growing biotech environment.

You will partner across Clinical Operations, CROs, vendors, and sites to drive study execution and ensure compliance with ICH-GCP and regulatory requirements. Responsibilities include TMF readiness, study start-up and close-out, risk mitigation, vendor oversight, site activation, and collaboration with cross-functional teams including

Qualifications

• Bachelor's degree in Life Sciences or related field; 5–7+ years in clinical trial operations
• Experience independently managing Phase I–IV trials and collaborating with CROs
• Strong knowledge of ICH-GCP and FDA global trial requirements
• Ability to lead cross-functional teams and manage multiple studies simultaneously
• Proficiency with CTMS, eTMF, EDC, IRT and related clinical systems

Responsibilities

• Lead day-to-day operational management of global clinical trials (Phase I–IV).
• Serve as primary operational lead ensuring milestones, timelines, budgets and quality targets are met.
• Oversee start-up, maintenance, close-out, and inspection readiness activities.
• Develop and finalize study documents including plans, manuals, newsletters, trackers, ICFs, protocols.
• Ensure TMF/eTMF completeness and inspection readiness.
• Identify risks and implement mitigation strategies with leadership escalation as needed.
• Oversee CROs and vendors, track performance and payments.
• Coordinate investigator/site selection and site activation activities.
• Lead operational study meetings and ensure timely completion of action items.
• Collaborate with Data Mgmt, Regulatory Affairs, Pharmacovigilance and other teams.

Skills

ICH-GCP knowledge

Trial management

FDA regulations

Cross-functional leadership

Project management

Vendor management

Mentoring

CTMS / EDC

Education

Bachelor's degree in Life Sciences

Tools

CTMS

eTMF

EDC

IRT

Job description

Madrigal Pharmaceuticals, Inc. is seeking a Clinical Trial Manager to independently lead global trials across phases I–IV in a fast-growing biotech environment.

You will partner across Clinical Operations, CROs, vendors, and sites to drive study execution and ensure compliance with ICH-GCP and regulatory requirements. Responsibilities include TMF readiness, study start-up and close-out, risk mitigation, vendor oversight, site activation, and collaboration with cross-functional teams including