Senior Clinical Trial Manager (Site/Study Blinding Specialist)
NeuronatherapeuticsSenior Clinical Trial Manager, Clinical Operations
(Site/Study Blinding Specialist)
Location: South San Francisco or Remote
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, then monitor plan adherence and effectiveness, identify and mitigate risks, and facilitate the resolution of operational site challenges, sharing 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.
Key Responsibilities
- 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 (eg 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 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.
Core Competencies
- Strategic thinking: Ability to link asset level goals with study level operational strategies and deliverables. Uses strategic thinking in innovative problem solving. Effectively present and contribute to discussions on study operations at program meetings and operational reviews for senior leadership.
- Commitment to Quality: Responsible for operational excellence and inspection readiness in all aspects of oversight for clinical studies in compliance with ICH/GCP, global regulations, and SOPs.
- Leadership: Demonstrates independence and critical thinking to lead cross functional teams; expertise in end-to-end clinical study operations management (all phases, set up to close out) and the ability to influence cross-functional teams to drive achievement of milestones.
- Communication & Organizational Skills: Strong organizational skills, attention to detail, and the ability to work effectively within a fast-paced, collaborative team environment. Able to communicate clearly and concisely and understand the audience (eg peers vs leaders; education vs driving decisions). Experienced with managing multiple priorities and ensuring the cross functional team and vendors are working together with aligned understanding.
- Study Management: Experience in end-to-end clinical trial management, including study design / planning, execution, financial/budget and timeline management, oversight, issue management, and creation of associated tools, training, and documentation.
- Vendor Oversight: Provide oversight on collaboration with external partners including requests for proposals (RFPs), vendor selection, scope development, contract review, budget evaluation & negotiation, SOW review/approval, data transfer planning, management of timelines and deliverables.
- Risk Management: Knowledge of quality standards, able to proactively identify risk, address and/or escalate study related issues; provide solutions to mitigate risk.
Physical Demands
The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is performed in an office environment. Travel may be required (up to 30%).
Education & Experience
- 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 and good experience partnering with Clinical Quality Assurance.
- Experience managing clinical trials with blinded and unblinded study personnel and processes would be advantageous for the independent development of site-level blinding strategies and oversight of study-specific blinding requirements at the site and CRA level.
Alert
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If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at https://www.cisa.gov/be-cyber-smart/report-incident to learn how to report it.
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.