Senior Clinical Trial Manager
Company: Ardence Consulting
- Location: United States
- Seniority: Senior
- Employment type: Contract
- Posted: 3 days ago
- Offer language: English
Job description
Sr. Clinical Trial Manager (Remote)
Duration: 6-12+ months with opportunity for conversion. Must be able to work EST hours. No third parties.
Our client is an innovative pharmaceutical company that is in immediate need of a Sr. CTM to support their existing and upcoming studies. This consultant will play a critical role in supporting the client’s clinical program, ensuring critical timelines and study milestones are met.
Primary Responsibilities:
- Support planning, implementation, execution, and management across all phases of the clinical studies.
- Support activities with CRO vendor, including start-up, maintenance, and closeout.
- Ensure compliance with ICH GCP, health authority regulations and internal SOPs.
- Support clinical site evaluation, site initiation, routine monitoring, and closeout visits.
- Support site activities, including ICF review, FAQ development, and timeline management.
- Assist in developing study plans, worksheets, and study tools.
- Review electronic case report forms (eCRFs) and associated user acceptance testing (UAT).
- Execute monitoring plans and ensure adequate support for monitoring and investigative site management activities.
- Collaborate with project management on key clinical development timelines and milestones, enrollment projections, and data delivery strategies.
- Maintain relationships with investigative site personnel, and CRO counterparts.
- Work cross-functionally to resolve potential data management and clinical operations issues.
- Review study data listings and electronic data capture systems for quality and completeness.
- Ensure protocol deviations are documented and implement associated CAPA plans.
Technical Requirements:
- BS Degree
- 10+ years of clinical trial experience
- Strong sponsor-side experience, preferably with small to mid-sized companies
- Experience developing clinical protocols
