Note: The job is a remote job and is open to candidates in USA. Syneos Health is a fully integrated life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Project Manager will lead Phase I and early development clinical trials from study startup through closeout, serving as the primary contact for sponsors and stakeholders while ensuring delivery on time, within budget, and in compliance with applicable standards and regulations.
Responsibilities
- Lead all aspects of assigned early-phase clinical trials from study startup through database lock and closeout
- Serve as the primary liaison between sponsors, internal teams, vendors, and study sites
- Develop and manage project timelines, milestones, resources, risks, finances, and deliverables
- Ensure projects are executed according to contractual commitments, study protocols, and operational plans
- Lead cross-functional project teams to achieve study goals while maintaining quality, timelines, and budget expectations
- Coordinate activities and deliverables across internal departments and external partners
- Maintain accountability for overall project financial performance, including budget management, forecasting, and change order identification
- Monitor project scope and proactively manage risks, issues, and resource requirements
- Develop contingency plans and risk mitigation strategies to ensure successful study execution
- Provide regular project status updates and reports to clients and senior leadership
- Ensure studies are conducted in compliance with GCP, ICH guidelines, company SOPs, and applicable regulatory requirements
- Maintain oversight of Trial Master File (TMF) quality, completeness, and inspection readiness
- Ensure accurate maintenance of study information within CTMS and other clinical systems
- Support audit and inspection readiness activities throughout the study lifecycle
- Maintain accountability for project documentation and all assigned study deliverables
- Build strong relationships with sponsors through consistent communication and successful project delivery
- Lead internal and external project meetings, including governance and study team meetings
- Present project updates, risks, mitigation plans, and key milestones to clients and executive stakeholders
- Participate in bid defense meetings and support business development initiatives as needed
- Identify opportunities for future business and expanded client partnerships
- Provide leadership and direction to cross-functional study teams
- Foster collaboration and accountability across operational functions
- Mentor junior team members and clinical operations staff as appropriate
- May provide line management responsibilities for project management and clinical monitoring personnel
Skills
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related scientific discipline; or an equivalent combination of education and experience
- Minimum of 5+ years of clinical research experience with progressive project management responsibilities
- Experience managing Phase I and/or early-phase clinical trials
- Strong knowledge of GCP, ICH guidelines, and global regulatory requirements
- Demonstrated ability to manage multiple projects in a fast-paced clinical research environment
- Strong financial management and budget oversight experience
- Exceptional organizational, problem-solving, and risk management skills
- Excellent verbal and written communication, presentation, and stakeholder management skills
- Ability to work independently while effectively leading cross-functional teams
- Proficiency with CTMS, eTMF, and related clinical trial technologies
- Willingness to travel approximately 25%
- Experience within a Contract Research Organization (CRO)
- Direct experience supporting First-in-Human (FIH), SAD, MAD, clinical pharmacology (i.e. DDI, TQT, FE, BA/BE), or proof-of-concept studies
- Experience managing studies involving healthy volunteers, specialty and/or patient populations
- Vendor management and oversight experience
- Previous people leadership or line management experience
- Experience with decentralized and technology-enabled clinical trials
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Remote work (pre-approved)
Company Overview
Company H1B Sponsorship