Senior Clinical Project Manager – Early Phase

🔥 14 hours ago

🌐 Canada, United States – Remote

🇨🇦 Canada – Remote 🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Lead and oversee Phase I and early development clinical trials from study start-up through closeout • Serve as the primary point of contact for sponsors and internal stakeholders • Lead assigned early-phase clinical trials from study startup through database lock and closeout • Liaise between sponsors, internal teams, vendors, and study sites • Develop and manage project timelines, milestones, resources, risks, finances, and deliverables • Ensure projects meet contractual commitments, study protocols, operational plans, quality, timelines, and budget expectations • Lead cross-functional project teams and coordinate activities across internal departments and external partners • Manage project budgets, forecasting, change orders, scope, risks, issues, and resource requirements • Develop contingency plans and risk mitigation strategies • Provide project status updates and reports to clients and senior leadership • Ensure compliance with GCP, ICH guidelines, company SOPs, and regulatory requirements • Oversee Trial Master File quality, completeness, and inspection readiness • Maintain study information in CTMS and other clinical systems • Support audit and inspection readiness activities • Maintain project documentation and assigned study deliverables • Build sponsor relationships through communication and successful delivery • Lead governance, study team, internal, and external project meetings • Present updates, risks, mitigation plans, and milestones to clients and executive stakeholders • Participate in bid defense meetings and support business development initiatives • 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 • May provide line management responsibilities for project management and clinical monitoring personnel

🎯 Requirements

• 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% • Preferred: Experience within a Contract Research Organization (CRO) • Preferred: Direct experience supporting First-in-Human (FIH), SAD, MAD, clinical pharmacology, or proof-of-concept studies • Preferred: Experience managing studies involving healthy volunteers, specialty and/or patient populations • Preferred: Vendor management and oversight experience • Preferred: Previous people leadership or line management experience • Preferred: 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 • Reasonable accommodations when appropriate