Senior Clinical Project Manager

Key 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.

Qualifications & Experience: 8+ years of clinical project management experience within a CRO, pharmaceutical, or biotechnology environment. Strong in-house CRO background preferred 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; advanced degree preferred. Strong communication, leadership, and Microsoft Office skills; fluent in English. Desirable 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.

Key Skills: 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.