Clinical Trial Manager

Venesco • Fort Detrick, MD

1d

About The Position

Venesco LLC is seeking Clinical Trial Managers to provide leadership and operational oversight for FDA-regulated clinical studies, ensuring studies are executed in accordance with approved protocols, budgets, timelines, regulatory requirements, and quality standards.

Requirements

• Bachelor's degree in Life Sciences or related field.
• Minimum 7 years of clinical trial management experience.
• Experience managing FDA-regulated studies.
• Strong understanding of ICH-GCP and FDA requirements.

Responsibilities

• Manage all phases of clinical trial startup, conduct, and closeout.
• Develop and maintain project plans and timelines.
• Coordinate protocol development and study documentation.
• Manage Trial Master File (TMF) documentation.
• Coordinate study working groups and stakeholder meetings.
• Ensure ClinicalTrials.gov registration and reporting requirements are met.
• Monitor study metrics and status reports.
• Coordinate interactions among sites, CROs, sponsors, and regulatory personnel.
• Identify operational risks and develop mitigation plans.
• Support FDA inspections and sponsor audits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level