Clinical Trial Manager (CTM)/Sr CTM, Clinical Operations
Nexcella, Inc.
Our 3 Core Values
* Intelligence
* Integrity
* Initiative
What You'll Do
The Clinical Trial Manager (CTM) leads the strategic and operational execution of cell therapy clinical trials, owning the full patient treatment pathway from apheresis through manufacturing, product release, and infusion. Serving as the cross-functional integrator across Clinical Operations, CMC, Manufacturing, Regulatory, Medical, Quality, and Supply Chain. The CTM ensures seamless execution, strict chain of identity and custody, inspection readiness, and on-time delivery of critical study milestones while safeguarding patient safety and product integrity
Key Responsibilities
* Lead and manage the day-to-day operational execution of assigned cell therapy trials: study startup, site activation, enrollment, monitoring, close-out.
* Develop and manage study timelines, budgets, forecasts, and related operational metrics.
* Partner with external vendors / CROs / service providers (monitoring, labs, imaging, manufacturing/supply chain for cell product) to ensure high quality and timely deliverables.
* Serve as the primary cross-functional operational contact for study teams (clinical operations, data management, biostatistics, regulatory, safety/pharmacovigilance, manufacturing, supply chain, medical affairs, quality).
* Ensure compliance with regulatory and quality standards (FDA, EMA, ICH-GCP, relevant local regulations) and internal SOPs.
* Participate in protocol development and amendments, informed consent form (ICF) review, CRF/data tool development, TMF (Trial Master File) setup & maintenance, monitoring plan, data review plan, drug/cell-product accountability and reconciliation.
* Oversee site feasibility, selection, contracting, start‐up (site initiation visits, training, enrollment & retention strategies) and close‐out activities.
* Monitor study progress, identify risks/issues (enrollment delays, monitor/vendor performance, budget overruns, data quality issues) and implement mitigation strategies.
* Foster effective communication across study teams, escalate issues to senior leadership as needed.
* Ensure preparation for audits/inspections, maintain high standards of documentation readiness.
* Contribute to lessons-learned and process improvement initiatives, particularly around cell-therapy-specific operational challenges (e.g., chain of identity/chain of custody, logistics of product, unique site training).
* Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations.
* Develop study documents and tools including study, informed consent forms, project plans, budgets, study templates, and other materials as needed.
* Vendor Management – Contribute to or lead cross-program vendor management activities
* Contribute to SOP development within the Clinical Operations team
Qualifications
* B.S. degree with minimum 7-10 years of experience in clinical operations including managing clinical trials in biotech, pharmaceutical.
* Strong clinical study conduct experience from start-up through close-out.
* Strong leadership, effective decision making, and problem-solving skills required.
* Established Cell Therapy /CAR T study experience preferred.
* Working knowledge of relevant GCPs and FDA/EMA regulations.
* Knowledgeable of current ICH GCP guidelines and applicable regulations.
* Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
* Experience in small/mid biotechnology environment (startup mindset)
* Excellent written and verbal communication skills
About Nexcella, Inc.
Nexcella, Inc. is a subsidiary of Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a "digital filter" that filters out non-specific activation. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a registrational design. Interim results were presented at ASCO 2025 in an oral presentation by Heather Landau, M.D. of Memorial Sloan Kettering Cancer Center. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn and