Job Description:

The Clinical Trial Manager is responsible for the operational management of clinical trials. The main responsibilities are management of early phase clinical trial/s including the direction, planning, execution and interpretation of clinical trials under ICH/Good Clinical Practices. This position requires routine interaction with key internal and external stakeholders, communicating clinical status, escalating issues, and troubleshooting routine inquiries. This position involves both operational strategy and study execution.

Responsibilities:
• Lead the trial and as such, manage internal and external stakeholders.
• Provide Clinical Operations expertise and strategic leadership in the evaluation, selection, and management of Global Contract Research Organizations (CROs) and other external vendors to ensure successful First in Human clinical trial implementation and execution in several compounds, indications and therapeutic areas.
• Proactively manage CRO in all... aspects of study progress from planning to close-out.
• Collaborate cross functionally with the program development functions to deliver trials according to plan and in the highest quality standards.
• Contribute to the development and presentation of clinical trial operational strategy and updates to senior/executive leadership.
• Oversee, manage, and ensure clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])
• Contribute to global regulatory submissions (FDA, EMA, and other governing regulatory bodies)
• Develop, review and approve Clinical Quality Documents
• Manage clinical trial budgets, providing ongoing financial reporting and projections.
• Facilitate the development of clinical trial agreements and other relevant documents.
• Contributes and/or authors the creation and finalization of key trial documentation: Protocols, Informed consent Forms, Investigator Brochures, Pharmacy Manual, Laboratory Manual, Manual of Operations, Clinical Study Report, etc.
• Liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships.
• management, safety management, and study communication plans)
• Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed.

Experience Required:
• 6+ years of experience in cell and/or gene therapy industry with at least 4+ years Clinical Affairs
• M.Sc. / Ph.D or M.D in relevant disciplines
• Strong knowledge of GCP and regulatory requirements
• Excellent written and oral English communication skills
• Good organizational abilities and attention to details
• Strong decision-making skills
• Overseas travel (as needed)
• High presentation and interpersonal skills

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Rehovot Israel

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