Clinical Trial Manager, Immunology

🔥 1 hour ago

🐊 Florida – Remote

🐊 Florida – Remote

💵 $145k - $165k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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Syncromune®

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $111.8M Series A - Syncromune on 2024-12

Biotechnology • Pharmaceuticals • Healthcare

Syncromune is a clinical-stage company developing a novel intratumoral cancer immunotherapy platform called SYNC-T. The platform is designed to be delivered directly into target tumors to synchronize the immune system to recognize and destroy cancer throughout the body. Its lead investigational therapy, SV-102, is being evaluated in the LEGION-100 Phase 2 trial for metastatic castration-resistant prostate cancer. The company’s materials are directed at healthcare professionals and note that its compounds are investigational and not yet approved by regulatory authorities.

📋 Description

• Works closely with various internal team members and vendors as well as clinical sites • Ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH/GCP • Responsible for leading and managing the conduct of complex drug/device combination immuno-oncology clinical trials from study start-up to closeout • Serves as the primary contact for clinical site personnel for trial activities and progress • Participates in protocol, CRF and strategy development • Prepares metrics and updates for management • Prepares and shares written and verbal reports on the status of clinical trials • Proactively identifies potential study issues/risks and recommends/implements solutions • Participates in and facilitates CRO/vendor selection process for outsourced activities • Manages CRO interactions, including sponsor oversight of operational activities • Prepares and/or reviews/approves study-related documents • Develop and maintain the Project Team List for assigned clinical trials • Manages clinical monitoring activities ensuring compliance with Good Clinical Practice (GCP) • Participates in the development, review, and implementation of departmental SOPs and processes • Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings.

🎯 Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related field • Additional clinical trial certifications (e.g., ACRP, SOCRA) are a plus • At least 5 years of experience in clinical research, clinical operations • Familiarity with clinical trial processes, Good Clinical Practice (GCP), and ICH guidelines • Strong experience in oncology clinical trials • Experience with phase I-II oncology studies from study start up through data lock • Solid understanding of GCP, ICH guidelines, and regulatory requirements • Strong scientific acumen and ability to grasp complex scientific and technical concepts • Familiarity with 21CFR, ISO, ICH, GCP, and relevant regulations, standards, directives, and guidance is essential • Excellent analytical and research skills, with a keen eye for detail • Exceptional communication, organizational, and problem-solving skills • Ability to work independently and collaboratively in a fast-paced, deadline-driven matrix environment • Ability to set priorities and accomplish assigned work within deadlines.

🏖️ Benefits

• This position generally is eligible for cash incentive compensation • equity incentive compensation • employee benefits under the Company’s benefit plans.