[Hiring] Senior Clinical Trial Manager @Neurona Therapeutics

Role Description

We are looking to hire a Senior Clinical Trial Manager (Sr. CTM) to serve as the primary unblinded Clinical Operations Lead, supporting clinical trial sites in a complex, double-blind cell therapy study. This role will partner closely with internal study teams, CRO staff, and sites in the logistical planning and execution of seamless study participant scheduling, assessments, and handoffs between blinded and unblinded clinical site staff.

This Sr. CTM would work directly with clinical site staff (coordinators, physicians, and IT staff) to:

• Develop robust site blinding and communication plans.
• Monitor plan adherence and effectiveness.
• Identify and mitigate risks.
• Facilitate the resolution of operational site challenges.
• Share best practices across clinical sites.

The Sr CTM achieves these objectives by bringing strong communication skills, strategic thinking, innovation, expertise in clinical study operations, and stakeholder management to address risks and develop solutions. Prior study coordinator experience would be beneficial.

This role will also include data review, study start-up, and CRO oversight responsibilities. As study demands evolve, this Sr. CTM may assume additional responsibilities, including oversight of a clinical study.

Qualifications

• Bachelor’s Degree or equivalent degree is required (preferably in a scientific or healthcare field).
• Minimum of 8 years in clinical study management, with at least 6 years of site/study management experience within a CRO or sponsor company preferred.
• Experience leading cross-functional internal teams and site management or CRO oversight.
• Multi-regional clinical trial experience is preferred.
• Previous study management in end-to-end study operations (study initiation through study completion) in Phase 1-3 drug and/or device studies.
• Strong understanding of GCPs, ICH, and knowledge of regulatory requirements.
• Good experience partnering with Clinical Quality Assurance.
• Experience managing clinical trials with blinded and unblinded study personnel and processes would be advantageous.

Requirements

• Implementation of study strategy into study-level operational execution within study team, CRO, and clinical sites.
• Oversee internal and external (site and CRO) study execution activities and proactively drive progress to meet milestones and Corporate and Department deliverables and goals.
• Provide oversight and guidance to unblinded CRAs, including review of monitoring strategies, monitoring reports, site issues, operational risks, and protocol compliance activities while maintaining trial integrity and study blinding.
• Lead meetings with good meeting hygiene practices (e.g., agendas, minutes, decision & action logs); may attend other higher-level team meetings.
• Conduct ongoing review of clinical and operational data to identify trends, protocol deviations, participant scheduling risks, product chain-of-identity/chain-of-custody concerns, and other issues requiring site intervention.
• Ensure delivery of required data and study documentation to comply with regulatory and government requirements (GDPR, Human Subject Protection training, Clinical Insurance, etc.).
• Prepare or oversee the development and ongoing review of Regulatory and Study documents.
• CRO oversight, including adherence to study timelines, risk registry, issue management, and operational logistics throughout the lifecycle of the study.
• Review study progress against KPIs, identify trends and work with respective SMEs/functional leads and CRO to deliver within agreed quality and performance indicators and/or oversee execution of remediation plans.
• Periodic review of TMF to ensure complete collection and quality checks of documents throughout study start-up, maintenance, and close-out periods.
• Develop and maintain study operational plans, risk management plans, and mitigation strategies to support achievement of study objectives.
• Oversight of other study vendors.
• Provide regular status updates and periodic in-depth operational reviews to senior leadership.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Flexible work hours and remote work options.
• Professional development opportunities.
• Generous paid time off and holiday schedule.

Company Description

This job description is not intended to be exhaustive and may evolve as business needs change. Duties, responsibilities, and activities may be modified or assigned at any time with or without notice.