Senior Clinical Project Manager

Responsibilities: Lead the planning and execution of clinical trials from startup to closeout for pharmaceutical and biotech clients. Specifically coordinate Data Monitoring Committee (DMC) activities, including meeting planning and deliverable readiness.

Requirements: Requires a bachelor's degree in life sciences or a related field and at least 7 years of clinical project management experience, preferably in a CRO environment. Must have demonstrated experience coordinating DMC activities and a strong understanding of ICH-GCP regulations.

Key skills: Clinical Project Management, DMC Coordination, Sponsor Relationship Management, Vendor Oversight, Risk Management, ICH-GCP, Clinical Trial Operations, Budget Tracking, Cross-functional Leadership, Timeline Management, Quality Compliance, Inspection Readiness, CTMS, EDC, eTMF, Microsoft Office

Keywords: Clinical Trials, CRO, DMC, IDMC, ICH-GCP, Pharmaceutical, Biotechnology, Medical Device, Clinical Operations, Data Management, Biostatistics, Statistical Programming, Medical Writing, Regulatory Affairs, CTMS, EDC, eTMF, Oncology, Rare Disease, CNS, Immunology, Decentralized Trials, eClinical Platforms, Interim Analysis, SOPs, Risk Register, Change Order, Global Clinical Trials, Matrix Environment, Inspection Readiness