Clinical Trial Manager
About this role
Description
Clinical Trial Manager
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
Duties and 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.
Minimum Qualifications
- 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.
Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.
For more information on Venesco, LLC., visit https://venesco.com.
Company at a glance
Venesco, LLC is a premier government contractor delivering Healthcare, IT, Research & Development, and a range of mission‑critical services to federal agencies. For more than 18 years, we’ve evolved from a small consulting firm into a respected leader in biomedical R&D and IT support, backed by strong financials, mature processes, and a commitment to employee connectedness and work–life balance.
Our success is driven by our skilled professionals, agile management practices, and high‑quality standards. Venesco holds a Top‑Secret Facility Clearance and maintains CMMI® Maturity Level 3 (Services) and ISO 9001:2015 and 14001:2015 certifications. We’ve been recognized on the Inc. 5000 and Washington Technology’s Fast 50 lists for five consecutive years.
With more than 350 credentialed employees and 65+ prime contracts — ranging from small teams to programs with 150+ personnel — we deliver the impact of a large enterprise while maintaining the agility of a small business. Venesco continues to recruit motivated, talented individuals who want to contribute to meaningful federal initiatives and join a collaborative, high‑performing team.
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