Senior Clinical Trial Manager

Lumicell • Waltham, MA

5d

About The Position

Lumicell is seeking an experienced Senior Clinical Trial Manager to lead operational execution of post-market clinical studies, registries, and observational research programs supporting the LumiSystem platform. This role serves as the primary operational lead for study start-up, site activation, investigator engagement, clinical trial management, and cross-functional study execution.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Public Health, or related field.
• Strong knowledge of ICH-GCP, FDA regulations, clinical trial operations, post-market research, registry studies, and site management.
• Experience with study start-up, site activation, contracting, and IRB processes.
• Experience coordinating CRAs and cross-functional study teams.
• Excellent communication, organizational, and project management skills.

Nice To Haves

• Advanced degree such as MPH, MS, RN, PharmD, or equivalent.
• Combination product experience or medical device experience.
• Oncology experience.
• Experience managing registries and post-market surveillance studies.
• Experience with EDC systems, eTMFs, and inspection readiness activities.
• Experience building study training materials and investigator-facing materials.
• Experience working in small-company or fast-paced clinical operations environments.

Responsibilities

• Serve as operational lead for post-market clinical studies, registries, observational studies, and clinical evidence generation programs.
• Develop and manage study timelines, milestones, risk mitigation plans, and site activation strategies.
• Lead study start-up activities from protocol finalization through first patient enrolled.
• Maintain oversight of study progress, enrollment, data quality, monitoring team, compliance, and operational performance metrics.
• Organize and lead recurring study team meetings and action item reviews.
• Collaborate with Clinical Affairs, Pharmacovigilance, Data Management, Biostatistics, Regulatory Affairs, Quality Assurance, Medical Affairs, Commercial Operations, and external study partners.
• Prepare study status updates for leadership, including enrollment forecasts, start-up metrics, action item status, and study risks.
• Lead issue escalations and facilitate resolution planning to maintain study momentum and alignment.
• Lead site outreach and recruitment activities for post-market studies.
• Lead and oversee site feasibility, qualification, and assessment processes, partnering with CRAs to ensure comprehensive evaluation of site capabilities, resources, recruitment potential, and operational readiness.
• Drive site selection, budget development, contract negotiation support, CTA/SOW execution, IRB readiness, regulatory document collection, and site readiness reviews.
• Track start-up performance and proactively remove barriers to activation.
• Coordinate site activation planning and study launch activities across multiple sites simultaneously.
• Act as primary sponsor contact for participating clinical trial sites.
• Manage investigator communications and maintain strong collaborative relationships.
• Conduct study introduction meetings, start-up meetings, and operational discussions with site personnel.
• Support publication and research collaboration opportunities with participating investigators.
• Lead planning, development, scheduling, and execution of Site Initiation Visits.
• Develop training materials, SIV presentations, agendas, and study-specific educational content.
• Coordinate cross-functional review and approval of study training materials.
• Present (or oversee presentation of) study procedures, data collection requirements, safety monitoring requirements, and operational workflows during SIVs.
• Ensure sites are fully trained and prepared for enrollment activation.
• Incorporate lessons learned from SIVs into future study operations and training materials.
• Partner with CRAs to ensure effective site monitoring activities.
• Review monitoring findings and support resolution of protocol deviations, data issues, and compliance concerns.
• Participate in development and maintenance of Clinical Monitoring Plans.
• Ensure appropriate oversight of study conduct and site performance.
• Provide timely responses to protocol, operational, and data collection questions.
• Maintain oversight of study TMF completeness and quality.
• Ensure essential study documents are filed throughout the study lifecycle.
• Coordinate TMF reviews, QC activities, closeout documentation, and inspection readiness activities.
• Support audit preparedness, inspection readiness initiatives, vendor transition documentation, and archiving activities as required.
• Develop, review, and maintain study start-up packets, site activation materials, Clinical Monitoring Plans, study manuals, operational plans, training presentations, enrollment tracking tools, action item logs, and study status reports.
• Ensure study documentation is current, controlled, traceable, and compliant with applicable regulations and company procedures.
• Coordinate activities performed by CROs, contractors, and external service providers.
• Manage vendor deliverables and timelines, escalate risks, and track issue resolution.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior