Senior Clinical Trial Manager
About The Position
Neurocentria is seeking a Senior Clinical Trial Manager to serve as the primary operational lead for two concurrent, fully decentralized Phase 2 clinical trials in neurology and cognitive health. The trials have no in-person clinic visits; assessments are conducted remotely or through local laboratory networks. This is a senior individual-contributor role on a lean internal team. The manager will work directly with the Principal Investigator and Head of Clinical Operations, overseeing day-to-day CRO performance, vendor relationships, budgets, timelines, and regulatory compliance from study startup through database lock.
Requirements
- Bachelor’s degree in life sciences, clinical research, nursing, or a related field.
- 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 such as REDCap, Medidata Rave, or equivalent.
Nice To Haves
- Advanced degree (MS, MPH, or PharmD).
- CNS, neurology, or cognitive health therapeutic area experience.
- 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).
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 escalate operational risks proactively, including enrollment trends, screen failure rates, dropout signals, data quality issues, and timeline slippage.
- Lead study startup activities, including CRO RFP coordination, proposal evaluation, and contract review; confirm 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.
Benefits
- 401(k) with above-market company contribution.
- Comprehensive medical, dental, vision, and life insurance, with 100% employee premium coverage and 50% dependent premium coverage.
- Paid time off including vacation, floating holiday, sick leave, and annual winter week shutdown.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
