Senior Clinical Trial Manager

Senior Clinical Trial Manager supports the execution of clinical trials to ensure compliance with protocols, GCP, and regulatory requirements. The role supports study document development, investigator and site selection, and identification and escalation of study, site, and vendor issues. Works closely with CROs, CRAs, data management, and vendors to ensure subject tracking, data quality and query resolution, investigational product accountability, budget and payment management, and timely trial progress reporting, including site initiation and monitoring activities and cross-functional collaboration.

Key Responsibilities:
- Prepare and finalize project/study documents, including informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments.
- Assist in selection of investigators and study sites.
- Identify and respond to site/study issues; recommend corrective actions and/or escalate to Clinical Operations Manager.
- Collaborate with CRO clinical trial managers to track and report subject information; support screening/randomization and protocol-required procedures.
- Collaborate with data management on CRFs and related documentation (study guides, reference binders, patient diaries, forms), including EDC/IVRS specification process and UAT.
- Ensure CRF data queries are resolved with data management and CRAs.
- Coordinate and manage investigational product accountability and reconciliation.
- Manage study budget and vendor payment processes (including investigative sites).
- Monitor and track clinical trial progress; provide status update reports.
- Assist in management of clinical trial vendors (IVRS, central labs, IRB, central ECG) with CRO and Clinical Operations Manager.
- Assist in oversight of study CRAs (e.g., review trip reports) and provide guidance on site issues.
- Participate in Site Initiation Visits (SIVs) and co-monitor regional sites for protocol and GCP adherence (as required).
- Identify and escalate site, vendor, and study issues to Clinical Operations Manager (as appropriate).
- Participate in clinical/department meetings as required; perform other duties as assigned.

Required & Desired Qualifications:
- Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) preferred.
- 7–10+ years of clinical trial experience.
- Experience supporting clinical trials across Phase I–IV.
- Experience working with CROs and/or external vendors.
- Biotech/pharmaceutical environment experience preferred.
- Exposure to early-phase/first-in-human studies a plus.
- Therapeutic experience in metabolic and/or cardiovascular clinical studies a plus.

Competencies/Skills:
- Familiarity with fast-paced, cross-functional biotech environments.
- Strong organizational skills and attention to detail.
- Ability to manage multiple studies and priorities.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).

Benefits:
- Full-time employees eligible for base salary, bonus, equity, and comprehensive benefits including flexible paid time off, medical/dental/vision, life/disability insurance, 401(k) (traditional/Roth/employer match), plus additional voluntary benefits and mental health benefits via EAP.

Application Instructions:
- Applications accepted on an ongoing basis via the Madrigal Careers site.