Infotree Global Solutions ยท 1 day ago
Senior Clinical Trial Management Specialist
Infotree Global Solutions is seeking a Senior Clinical Trial Management Specialist who will be responsible for the planning, execution, and oversight of clinical trials. This role involves cross-functional collaboration, vendor and CRO oversight, and ensuring compliance with regulatory requirements to deliver high-quality clinical trials.
Human ResourcesStaffing AgencyTechnical Support
Responsibilities
Lead and support CRO and vendor selection, including participation in RFP development, bid evaluations, and selection processes
Provide ongoing vendor and CRO management, including oversight of performance, timelines, budgets, deliverables, and issue resolution
Draft, review, and coordinate cross-functional input for clinical trial documents, including:
Clinical protocols
Informed consent forms (ICFs)
Case report forms (CRFs)
Monitoring plans
Oversee and/or perform site monitoring activities, ensuring compliance with protocol, GCP, regulatory requirements, and company SOPs
Serve as a key liaison between internal stakeholders, CROs, vendors, and investigative sites
Track study milestones, risks, and issues; proactively develop and implement mitigation plans
Support study start-up, conduct, and close-out activities
Ensure accurate documentation, reporting, and maintenance of Trial Master File (TMF) content
Qualification
Required
Bachelor's degree (BS or BA) in life sciences or a related field required
4+ years of clinical trial management experience, preferably in a pharmaceutical, biotechnology, or CRO environment
Hands-on experience with site monitoring and study oversight
Demonstrated experience in CRO/vendor selection and vendor management
Strong understanding of ICH-GCP, FDA, and global regulatory requirements
Experience drafting and reviewing clinical trial documentation
Strong organizational, communication, and cross-functional collaboration skills
Ability to manage multiple priorities and work independently in a fast-paced environment
Experience working in a global clinical trial environment
Familiarity with electronic data capture (EDC) and CTMS systems
Company
Infotree Global Solutions
Infotree Global Solutions is a talent management company specializing in staffing and payroll solutions.
H1B Sponsorship
Infotree Global Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (9)
2023 (11)
2022 (17)
2021 (16)
2020 (19)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Kingswood Capital Management
2025-02-20Private Equity
Recent News
Company data provided by crunchbase