Clinical Trial Manager — FDA-Regulated Studies Leader

Venesco,-LLC-; Frederick (MD); On-site; USD 110,000 - 160,000; Full time

Job summary

Venesco, LLC in Maryland is seeking a Clinical Trial Manager to provide leadership and operational oversight for FDA-regulated studies, ensuring protocols, budgets, timelines, regulatory requirements, and quality standards are met.

The role focuses on startup, conduct, and closeout phases, coordination with sites, CROs, sponsors, TMF management, and inspections readiness, leveraging strong knowledge of ICH-GCP and FDA expectations.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 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.

Skills

Clinical trial management

FDA-regulated studies

ICH-GCP knowledge

Stakeholder coordination

Education

Bachelor's degree in Life Sciences or related field

Job description

Venesco, LLC in Maryland is seeking a Clinical Trial Manager to provide leadership and operational oversight for FDA-regulated studies, ensuring protocols, budgets, timelines, regulatory requirements, and quality standards are met.

The role focuses on startup, conduct, and closeout phases, coordination with sites, CROs, sponsors, TMF management, and inspections readiness, leveraging strong knowledge of ICH-GCP and FDA expectations.