Note: The job is a remote job and is open to candidates in USA. Clinovo is seeking a Clinical Trial Manager to direct and coordinate the operational execution of clinical studies from initiation through completion. The role oversees study operations, vendors, site management, timelines, budgets, quality, and regulatory compliance while coordinating cross-functional stakeholders and supporting full clinical trial lifecycle delivery.
Responsibilities
- Lead the operational management of assigned clinical studies, ensuring activities are conducted in accordance with study objectives, timelines, budget expectations, GCP, ICH guidelines, and applicable regulatory requirements
- Coordinate and facilitate collaboration among cross-functional stakeholders, including internal teams, CROs, and external vendors, to support successful study execution
- Oversee laboratory sample collection activities and maintain effective partnerships with laboratory vendors in coordination with relevant functional groups
- Create and manage study-related documents, including informed consent forms, training resources, and operational tools
- Contribute to the development and review of study protocols, case report forms (CRFs), monitoring plans, edit check specifications, vendor requirements, and related study documentation
- Review, approve, and provide final signoff for essential trial documents and study deliverables
- Monitor CRO and vendor performance against contractual obligations, study requirements, and quality standards, escalating issues and risks when necessary
- Serve as a subject matter resource on protocol requirements and provide guidance to study stakeholders
- Proactively identify operational risks and partner with cross-functional teams to implement mitigation and contingency plans
- Maintain oversight of study timelines, milestones, and deliverables, providing regular status updates and forecasts to leadership
- Track and analyze key operational metrics, including enrollment progress, patient visits, monitoring activities, data entry status, and data review activities
- Support budget management activities by reviewing contracts, evaluating invoices, and ensuring services align with approved statements of work
- Contribute to the development, refinement, and implementation of standard operating procedures (SOPs) and operational best practices
Skills
- Bachelor's degree in Life Sciences, Healthcare, Nursing, or a related discipline
- Minimum of three years of progressively responsible clinical operations or clinical trial management experience within a pharmaceutical, biotechnology, or CRO environment
- Demonstrated experience managing studies throughout the full clinical trial lifecycle, from study start-up through closeout, including inspection and audit readiness
- Prior oncology clinical research experience is required
- Proven ability to lead cross-functional teams, facilitate productive meetings, and drive effective communication across stakeholders
- Solid understanding of Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and other applicable clinical research requirements
- Experience overseeing and managing third-party vendors, service providers, and CRO partnerships
- Familiarity with global clinical research programs, including studies conducted globally
- Working knowledge of related functional areas such as data management, biostatistics, regulatory affairs, drug safety, and pharmacovigilance
- Strong written and verbal communication skills, with the ability to build productive working relationships across diverse teams
- Highly organized with the ability to independently prioritize competing activities and meet deadlines
Company Overview
Company H1B Sponsorship