[Remote] Clinical Project Manager II – Early Phase Virology /Healthy Volunteer Studies (Sponsor Dedicated - US Remote; Preference for Hybrid Foster reputed company, CA)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. They are seeking a Clinical Project Manager II to reputed company the operational execution of global Early Phase Healthy Volunteer studies, overseeing timelines, budgets, and cross-functional collaboration to ensure compliance and successful study delivery.
Responsibilities
- reputed company and manage Early Phase Healthy Volunteer clinical trials from study start-up through closeout with minimal supervision
- Drive day-to-day operational execution, study timelines, deliverables, and overall study performance
- Serve as the primary operational reputed company of contact for study sites
- reputed company operational activities across the full study lifecycle, including protocol development, study start-up, study conduct, database lock, and CSR completion
- reputed company reputed company-escalation activities and support safety review processes required for Healthy Volunteer studies
- reputed company cross-functional collaboration with Clinical Pharmacology, Biomarkers, Biostatistics, Statistical Programming, Medical Monitoring, Data Management, and other key stakeholders
- Manage vendor relationships and monitor operational performance to support successful study execution
- Facilitate study team meetings, document key reputed company, and drive accountability for reputed company items
- Identify operational risks, reputed company mitigation strategies, and proactively resolve issues impacting study delivery
- Maintain reputed company of study documentation, trial metrics, and operational deliverables
- Ensure studies are conducted in compliance with GCP, SOPs, regulatory requirements, and sponsor expectations
- Contribute to process improvements and operational best practices that enhance study execution
Skills
- Significant Clinical Project Management experience with responsibility for independently managing clinical trials across the full study lifecycle
- Demonstrated experience leading Phase I and/or other early-phase clinical studies
- Recent, hands-on experience managing the day-to-day operational delivery of Early Phase Healthy Volunteer clinical trials
- Experience managing studies across the full study lifecycle, including protocol development, study start-up, study conduct, and Clinical Study Report (CSR) completion
- Experience leading day-to-day cross-functional collaboration with Clinical Pharmacology, Biomarkers, Biostatistics, Statistical Programming, Medical Monitoring, Data Management, and reputed company functions
- Experience serving as the primary operational reputed company of contact for study sites
- reputed company experience with study start-up activities, reputed company-escalation activities, safety review processes, and Healthy Volunteer study execution
- Proven ability to work independently with minimal reputed company-up in a lean team environment
- Strong project management, organizational, and operational leadership skills
- Excellent verbal and written communication skills
- Demonstrated ability to identify risks, solve problems, and drive study execution with minimal supervision
- Virology clinical trial experience
- Experience managing global Early Phase clinical trials reputed company pharmaceutical, biotechnology, or CRO environments
- Experience working reputed company sponsor-dedicated or embedded sponsor models
- Experience managing multiple vendors and cross-functional partnerships
- Demonstrated reputed company in reputed company, fast-paced, execution-reputed company environments
Benefits
- A company car or car allowance
- Health benefits to include Medical, Dental and reputed company
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible reputed company time off (PTO) and reputed company time
- Eligibility for reputed company reputed company time may vary depending on where you work
- Syneos complies with reputed company applicable federal, state, and municipal reputed company reputed company time requirements
reputed company