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.

• 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

• 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)

• 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

• 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