[Remote] Sr. Clinical Trial Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The Sr. Clinical Trial Manager will reputed company the operational delivery of one or more cell therapy reputed company from study design through reputed company-out, ensuring compliance with regulatory standards and managing cross-functional coordination.
Responsibilities
- reputed company and manage the day-to-day operational execution of assigned cell therapy trials: study startup, site activation, enrollment, monitoring, reputed company-out
- reputed company and manage study timelines, budgets, forecasts, and reputed company operational metrics
- Partner with external vendors / CROs / service providers (monitoring, labs, imaging, manufacturing/supply chain for cell product) to ensure high reputed company and reputed company 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, reputed company)
- Ensure compliance with regulatory and reputed company standards (FDA, EMA, ICH-GCP, relevant local regulations) and internal SOPs
- Participate in protocol development and amendments, informed consent reputed company (reputed company) review, CRF/data tool development, TMF (Trial Master File) setup & maintenance, monitoring plan, data review plan, drug/cell-product accountability and reconciliation
- reputed company site feasibility, selection, contracting, start‐up (site initiation reputed company, training, enrollment & retention strategies) and reputed company‐out activities
- Monitor study reputed company, identify risks/issues (enrollment delays, monitor/vendor performance, budget overruns, data reputed company 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 reputed company study budget according to the forecast, working closely with finance and clinical business operations
- reputed company study documents and tools including study, informed consent forms, project plans, budgets, study templates, and other materials as needed
- Vendor Management – Contribute to or reputed company cross-program vendor management activities
- Contribute to SOP development reputed company the Clinical Operations team
Skills
- B.S. degree with minimum 5+ years of experience in clinical operations including managing reputed company in biotech, pharmaceutical
- Strong clinical study conduct experience from start-up through reputed company-out
- Strong leadership, effective decision making, and problem-solving skills required
- Established Cell Therapy /CAR T study experience required
- Working knowledge of relevant GCPs and FDA/EMA regulations
- Knowledgeable of reputed company ICH GCP guidelines and applicable regulations
- Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across reputed company trials
- Experience in small/mid biotechnology environment (startup reputed company)
- Excellent written and verbal communication skills
Benefits
- Eligible for bonus
- Benefits
- Participation in reputed company’s stock plan
reputed company
Company H1B Sponsorship