Clinical Program Manager – Regional & Vendor Oversight

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the Global Study Lead for a significant, worldwide Phase 3 clinical trial within a Phase 3 program.

• Provide oversight for Clinical Operations across designated regions, CROs, and vendors.

• Ensure uniform execution in line with study plans, timelines, quality standards, and regulatory obligations.

• Monitor study performance, detect operational risks and trends, and facilitate prompt resolution of issues.

• Supervise the execution of regional studies, encompassing site start-up, enrollment, monitoring, site performance, and continuous study conduct.

• Track CRO and vendor performance, study metrics, and operational trends.

• Promote timely mitigation, escalation, and corrective actions.

• Support activities related to inspection and audit readiness, as well as the remediation of documentation deficiencies.

• Ensure adherence to applicable regulations, ICH-GCP, SOPs, and study-specific plans.

• Collaborate with Clinical Research, Data Management, Biostatistics, Regulatory, and Quality stakeholders.

• Provide updates to leadership and study teams regarding regional and vendor performance, key risks, and inspection readiness.

• Contribute to essential study documents and engage in oversight activities for CROs, vendors, and sites, including participating in site visits.

• Manage or offer functional leadership to Clinical Operations staff as necessary.

• Set goals, metrics, interim reviews, and policy communication for reporting personnel.

⛳️ Requirements

• Minimum of 8+ years of pertinent clinical research experience and a BS, BA, BN in a relevant scientific field, or at least 8+ years of clinical research experience along with an RN (2 or 3 year certificate).

• Relevant clinical trial experience supporting large-scale, global Phase 3 studies or programs within the pharmaceutical, biotechnology, or healthcare sectors.

• Experience in MASH (formerly NASH), MASLD, and/or metabolic diseases is preferred.

• Proven experience with regional study oversight, CRO/vendor management, and operational performance.

• Experience in preparing for clinical trial inspections and audits, including the identification and resolution of operational or documentation gaps.

• Strong operational, problem-solving, and risk management abilities with a keen attention to detail.

• Comprehensive knowledge of FDA/EMA regulations, ICH guidelines, and GCP requirements.

• Excellent communication and collaboration skills, capable of working effectively across global, cross-functional teams.

• Willingness to travel up to 25%.

🏝️ Benefits

• Company bonus based on individual and organizational performance.

• Long-term incentive compensation.

• Medical, dental, and vision coverage.

• Life insurance.

• Disability insurance.

• 401(k) savings plan.

• Flexible spending accounts.

• Employee assistance program.

• Tuition reimbursement program.

• Group legal benefits.

• Critical illness insurance.

• Identity theft protection.

• Pet insurance.

• Auto/home insurance.

• Sick time policy.

• Flexible vacation policy.

• Parental leave policy.