Senior Clinical Project Manager (US)

📋 Description

• • Own the full life-cycle of complex, multinational clinical research projects across multiple modalities and therapeutic areas, acting as the single point of accountability for Sponsor success and ensuring every study is delivered on time, within budget, and to the highest regulatory standards.
• • Translate Sponsor strategy into executable operational plans by developing detailed project protocols, risk management frameworks, resource models, and integrated timelines that satisfy FDA, EMA, ICH-GCP, and corporate quality requirements.
• • Build, lead, and inspire cross-functional teams that can span biostatistics, data management, regulatory affairs, clinical operations, and third-party vendors; delegate with precision, resolve conflicts quickly, and mentor junior staff so that every team member performs at their peak.
• • Drive continuous financial stewardship: forecast spend, track burn-rate against scope, negotiate change orders, and implement cost-containment measures to protect Sponsor margins while safeguarding scientific integrity.
• • Serve as the primary Sponsor liaison from kick-off through database lock, orchestrating weekly status calls, steering committees, risk-based monitoring visits, and ad-hoc escalation calls to ensure transparent communication and rapid issue resolution.
• • Author and maintain critical project documents—including protocols, informed consent forms, case report forms, monitoring plans, and SOPs—ensuring version control, regulatory compliance, and seamless inspection readiness at all times.
• • Champion quality improvement by designing and executing CAPA plans, leading cross-functional lessons-learned sessions, and feeding insights back into R&D and Business Development to refine future proposals and service offerings.
• • Partner with clinical sites and patient recruitment vendors to co-create enrollment strategies, feasibility assessments, and retention programs that accelerate patient access and enhance diversity within study populations.
• • Represent Alimentiv at scientific conferences, bid defenses, and industry working groups, positioning the organization as a thought leader in innovative trial design and decentralized clinical research.
• • Provide expert coaching and peer mentoring to new Clinical Project Managers, delivering orientation curricula, sharing therapeutic-area insights, and acting as the first escalation point for Sponsor or site queries on pre-assigned projects.
• • Leverage advanced project management methodologies (PMP, Agile, risk-based quality management) to introduce efficiencies—such as remote source data verification, eConsent, and ePRO—that reduce site burden and improve data quality.
• • Ensure all project deliverables are inspection-ready by maintaining TMF completeness, audit trail integrity, and real-time compliance dashboards that satisfy both Sponsor and regulatory authority expectations.
• • Anticipate geopolitical, regulatory, and operational risks across North America, Europe, and Asia-Pacific, developing contingency plans that safeguard patient safety, data integrity, and project timelines.
• • Collaborate with Business Development to scope new opportunities, draft proposal text, build realistic budgets, and defend bids in live presentations to prospective Sponsors.
• • Foster a culture of continuous learning by staying current with evolving FDA guidance, EMA reflection papers, and innovative trial technologies, then cascading knowledge to internal teams and external partners.