Senior Clinical Trial Manager

The Role We are looking for a Senior Clinical Trial Manager to serve as the primary operational lead for two concurrent decentralized Phase 2 clinical trials in neurology and cognitive health. Both studies are fully decentralized — no in-person clinic visits — with all assessments conducted remotely or through local laboratory networks. This is a senior individual contributor role within a lean internal team. You will work directly with the Principal Investigator and Head of Clinical Operations, owning day-to-day CRO performance, vendor relationships, budgets, timelines, and regulatory compliance from study startup through database lock. Responsibilities Serve as the primary sponsor-side point of contact for the full-service DCT CRO, monitoring performance weekly against contractual deliverables across both trials Identify and elevate operational risks proactively — enrollment trends, screen failure rates, dropout signals, data quality issues, and timeline slippage — before they become milestone failures Lead study startup activities including CRO RFP coordination, proposal evaluation, and contract review; confirm all regulatory gates are cleared before enrollment opens Maintain Trial Master File completeness and audit readiness; track and triage protocol deviations and SAE reporting timelines Manage trial budgets and CRO invoicing across both studies; evaluate change order requests and prepare recommendations for approval Support IND amendments, IRB submissions, and regulatory authority interactions as directed by the Principal Investigator Required Qualifications Bachelor’s degree in life sciences, clinical research, nursing, or a related field; advanced degree preferred (MS, MPH, PharmD) Minimum 8 years of clinical trial operations experience in the pharmaceutical or biotechnology industry Demonstrated experience as primary operational lead on at least one Phase 2 or later IND-quality clinical trial, from startup through database lock Minimum 3 years of direct CRO oversight in a sponsor-side role, including vendor selection, performance management, and change order negotiation Experience with decentralized clinical trials (DCT) or hybrid trial models, including remote subject management, electronic consent, and digital endpoint or ePRO platforms Strong working knowledge of ICH GCP guidelines (E6 R2/R3), 21 CFR 312, and eTMF standards Proficiency with EDC systems (REDCap, Medidata Rave, or equivalent) Preferred Qualifications CNS, neurology, or cognitive health therapeutic area experience strongly preferred Experience with blood-based biomarker logistics in a clinical trial setting Familiarity with digital cognitive assessment platforms or tablet-administered endpoint technology Experience with patient recruitment in biomarker-enriched or specialty populations CDISC SDTM familiarity and experience with datasets for regulatory submissions ACRP or SOCRA certification (CCRC, CCRP, CCRA) is a plus What We Offer Primary operational ownership of two concurrent clinical programs at a pivotal stage of company development Direct daily collaboration with the Principal Investigator and Head of Clinical Operations in a lean, science-driven team Salary range: $160,000 – $190,000 (commensurate with experience and qualifications) 401(k) with above-market company contribution Comprehensive medical, dental, vision, and life insurance (100% employee premium coverage; 50% dependent premium coverage) Paid time off including vacation, floating holiday, sick leave, and annual winter week shutdown #J-18808-Ljbffr