Senior Clinical Trial Manager Lumicell Waltham, MA Job Details Full-time 11 hours ago Qualifications ICH guidelines Bachelor's degree Clinical data registries Managing clinical research teams Leading team collaboration initiatives Vendor contract management Biomedical regulatory compliance Communication with regulatory authorities for clinical trials Clinical quality assurance standards Project contract management Ethical review application preparation Cross-functional team management Cross-functional communication Leading research teams FDA regulations Full Job Description 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. Primary Responsibilities Study leadership and clinical operations 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. Site identification, feasibility, and selection 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 Site start-up and activation 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. Investigator and site relationship management 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. Site Initiation Visits and study trai ning 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. Clinical monitoring oversight 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. Trial Master File and inspection readiness 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. Study documentation and operational materials 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. Vendor and CRO oversight Coordinate activities performed by CROs, contractors, and external service providers. Manage vendor deliverables and timelines, escalate risks, and track issue resolution.

Required Qualifications:

Bachelor's degree in Life Sciences, Nursing, Public Health, or related field. Bachelor's degree in Life Sciences, Nursing, Public Health, or related field. 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.

Preferred Qualifications:

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.

Critical Success Factors:

Exceptional ownership and accountability Strong site engagement and investigator relationship management skills Excellent cross-functional leadership and follow-through Ability to convert clinical strategy into practical operational execution Ability to independently manage multiple studies and competing priorities Expertise in study start-up, activation, and site readiness Detail-oriented documentation practices Inspection-ready mindset Lumicell is advancing innovative technologies designed to improve cancer care and surgical outcomes. The Senior Clinical Trial Manager will play a central role in generating high-quality post-market clinical evidence and supporting clinical adoption of the LumiSystem platform through collaborative, compliant, and inspection-ready study execution. Lumicell is committed to a diverse and inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values. Lumicell is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Lumicell will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.