Clinical Trials Manager (MD)

The Clinical Trial Manager (CTM) will lead and coordinate clinical trial activities for Phase I-III studies, with a primary focus on autoimmune diseases and desired expertise in Cell & Gene Therapy. Working closely with the Head of Clinical Operations, the CTM will oversee study start-up, management, and completion in alignment with the company's SOPs, ICH/GCP regulations, and study-specific procedures. This role requires excellent communication skills, meticulous attention to detail, and the ability to collaborate effectively within a multidisciplinary team.

• Trial Coordination: Maintain site, vendor, and study team contact information; assist in study start-up, investigator recruitment, and regulatory document collection.
• Site Communication: Liaise with sites to facilitate document collection from start-up through study closure.
• Risk Management: Identify study risks, develop mitigation plans, and communicate with management as needed.
• Document Management: Create and maintain study documents, including training materials, study plans, and reports; ensure Trial Master File remains inspection-ready.
• Data and Quality Control: Support data entry and query resolution, perform QC reviews, and manage study trackers for regulatory timelines, protocol issues, and site performance.
• Team Collaboration: Participate in study meetings, manage field CRAs, train vendors, and ensure protocol compliance.
• Regulatory Support: Prepare and manage submissions for Health Authorities and Ethics Committees.
• Investigational Product Oversight: Track, ship, and reconcile Investigational Product inventory at clinical sites.
• Budget and Finance: Assist with site budget negotiations and invoice reviews.
• Study Progress Tracking: Track site activation, patient enrollment, and monitor visits, reporting on study progress.

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred.
• Minimum of 4 years as a Clinical Trial Manager, with experience in Phase I-III trials in the Autoimmune therapeutic area.
• Expertise in Cell & Gene Therapy trials is highly desired.
• Strong knowledge of GCP, FDA, and ICH regulations.
• Proven ability to manage multiple tasks in a fast-paced environment, with excellent organizational and communication skills.
• Certification as a Clinical Research Professional (CCRP) or equivalent is a plus.
• Proficiency in Microsoft Office Suite and familiarity with electronic data capture (EDC) systems.
• Ability to travel up to 50%, both domestically and internationally.

This is a full time position