Senior Clinical Trial Manager

Neurocentria, Inc.; Walnut Creek (CA); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

401(k) with above-market company match

Comprehensive medical, dental, vision,

Life insurance

Job summary

Neurocentria, Inc. is seeking a Senior Clinical Trial Manager to lead two concurrent fully decentralized Phase 2 trials in neurology and cognitive health. You will own day-to-day CRO performance, budgets, timelines, and regulatory compliance from startup through database lock.

This senior individual contributor role collaborates directly with the Principal Investigator and Head of Clinical Operations in a lean team to ensure trials advance on time and within scope.

Qualifications

• Bachelor’s degree in life sciences or clinical research required.
• Advanced degree preferred (MS/MPH/PharmD).
• Minimum 8 years of clinical trial operations experience.
• Minimum 3 years of sponsor-side CRO oversight.
• Experience with decentralized or hybrid trials.

Responsibilities

• Sponsor-side lead for two decentralized Phase 2 trials; oversee CRO performance.
• Identify operational risks and mitigation strategies.
• Lead study startup, CRO RFPs, and contract reviews.
• Maintain Trial Master File and SAEs reporting timelines.
• Manage budgets and CRO invoicing; approve change orders.
• Support IND amendments, IRB submissions, and regulatory interactions.

Skills

CRO oversight

DCT experience

IND regulatory knowledge

EDC systems

GCP knowledge

Budget management

Education

Bachelor’s degree in life sciences, clinical research, nursing, or related field

MS / MPH / PharmD preferred

Tools

REDCap / Medidata Rave

Job description

About Neurocentria

Neurocentria is a clinical-stage neuroscience company developing magnesium L‑threonate (MgT) as a precision intervention for cognitive health and neurological disorders. Our lead compound uniquely elevates brain magnesium by crossing the blood–brain barrier — a mechanism of action originating from 20 years of research. Two completed human trials have demonstrated significant cognitive effects, and our current clinical program represents a pivotal scientific and commercial milestone for the company.

About Neurocentria

Neurocentria is a clinical-stage neuroscience company developing magnesium L‑threonate (MgT) as a precision intervention for cognitive health and neurological disorders. Our lead compound uniquely elevates brain magnesium by crossing the blood–brain barrier — a mechanism of action originating from 20 years of research. Two completed human trials have demonstrated significant cognitive effects, and our current clinical program represents a pivotal scientific and commercial milestone for the company.

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 escalation 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