Senior Clinical Project Manager

Job Description

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

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• Lead the planning, execution, and delivery of a pediatric clinical study from start-up through closeout.
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• Serve as the primary operational contact for the sponsor and build a strong, consultative client relationship.
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• Lead cross-functional study teams and coordinate internal resources, vendors, CRAs, and Clinical Trial Leads.
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• Manage study timelines, budgets, forecasts, risks, scope changes, and overall quality.
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• Proactively identify challenges, develop mitigation plans, and escalate issues appropriately.
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• Ensure study activities comply with ICH-GCP, regulatory requirements, study contracts, and internal SOPs.
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• Maintain inspection readiness and provide clear, consistent updates to internal and external stakeholders.
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Requirements

Qualifications & Experience

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• 8+ years of clinical project management experience within a CRO, pharmaceutical, or biotechnology environment.
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• Strong in-house CRO background preferred
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• Proven experience leading global or regional clinical trials.
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• Experience in respiratory, complex oncology, pediatrics/NICU. advanced therapies, or similarly complex studies.
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• Strong vendor management and sponsor/client-facing experience.
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• Experience with proposals, contracts, account management, or other business development activities.
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• Strong knowledge of ICH-GCP, regulatory requirements, and drug/device development.
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• Experience with EDC, eTMF, and other clinical trial systems.
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• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field; advanced degree preferred.
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• Strong communication, leadership, and Microsoft Office skills; fluent in English.
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Desirable

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• Experience with pricing models, proposals, or portfolio management.
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• PMP certification or equivalent project management training.
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• Knowledge of Phase I trials and pharmacokinetics.
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• Experience coaching or mentoring team members.
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Key Skills

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• Excellent communication, negotiation, and presentation skills.
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• Strong stakeholder management across internal and external teams.
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• Strategic mindset with a balance of operational and commercial priorities.
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• Proactive, reliable, and committed to delivering high-quality work on time.
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• Strong organizational and administrative skills.
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