Senior Clinical Project Manager

Remote – Candidates must be based on the Eastern or Central Time Zones ONLY

Salary will be determined based on experience.

We are partnering with a growing CRO seeking an experienced Senior Clinical Project Manager to lead the end-to-end delivery of complex clinical trials. The role will oversee study timelines, budgets, risks, quality, and cross-functional teams, while serving as the primary sponsor contact and ensuring projects are delivered in line with contractual, regulatory, and GCP requirements.

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.

Requirements

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.