Note: The job is a remote job and is open to candidates in USA. BioTalent is partnering with a growing contract research organization (CRO) to deliver complex clinical trials. The Senior Clinical Project Manager will lead pediatric clinical studies from start-up through closeout, managing timelines, budgets, risks, quality, vendors, and cross-functional teams while serving as the primary sponsor contact and ensuring compliance with contractual, regulatory, and GCP requirements.
Responsibilities
- Lead the planning, execution, and delivery of a pediatric clinical study from start-up through closeout
- Serve as the primary operational contact for the sponsor and build a strong, consultative client relationship
- Lead cross-functional study teams and coordinate internal resources, vendors, CRAs, and Clinical Trial Leads
- Manage study timelines, budgets, forecasts, risks, scope changes, and overall quality
- Proactively identify challenges, develop mitigation plans, and escalate issues appropriately
- Ensure study activities comply with ICH-GCP, regulatory requirements, study contracts, and internal SOPs
- Maintain inspection readiness and provide clear, consistent updates to internal and external stakeholders
Skills
- Remote – Candidates must be based on the Eastern or Central Time Zones ONLY
- • 8+ years of clinical project management experience within a CRO, pharmaceutical, or biotechnology environment
- • Proven experience leading global or regional clinical trials
- • Experience in respiratory, complex oncology, pediatrics/NICU. advanced therapies, or similarly complex studies
- • Strong vendor management and sponsor/client-facing experience
- • Experience with proposals, contracts, account management, or other business development activities
- • Strong knowledge of ICH-GCP, regulatory requirements, and drug/device development
- • Experience with EDC, eTMF, and other clinical trial systems
- • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field
- • Strong communication, leadership, and Microsoft Office skills; fluent in English
- • Experience with pricing models, proposals, or portfolio management
- • PMP certification or equivalent project management training
- • Knowledge of Phase I trials and pharmacokinetics
- • Experience coaching or mentoring team members
- • Excellent communication, negotiation, and presentation skills
- • Strong stakeholder management across internal and external teams
- • Strategic mindset with a balance of operational and commercial priorities
- • Proactive, reliable, and committed to delivering high-quality work on time
- • Strong organizational and administrative skills
- • Strong in-house CRO background preferred
- Advanced degree preferred
Benefits
- Remote work arrangement for candidates based in the Eastern or Central Time Zones only
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