Clinical Trials Director

The Director of clinical trials is responsible for the successful execution of clinical trials from the protocol concept through the clinical study report; Ensures completion of study deliverables in terms of design, location, phase, etc. Proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required. Contributes to the development of SOPs, clinical development plans, and other company initiatives as required.

You will be part of the company's Clinical/ RA/ QA department. Trials take place in Israel, EU, USA and other territories overseas.

Responsibilities

• Managing all clinical aspects of study including: Assess the operational feasibility and prepare study execution plan
• Develop and manage comprehensive study timelines and metrics
• Provides study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel
• Use operational and therapeutic expertise to optimize trial design and execution
• Works with the study team to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure appropriate patient recruitment, detection of data trends and to ensure study objectives are met
• Ensure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs: Participate in the planning of quality assurance activities and coordinate resolution of audit findings; Ensure audit-ready condition of clinical trial documentation including central clinical files; Reviews monitoring reports to ensure quality and resolution of site-related issues; Coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate.
• Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws, while maintaining clear instructions for procedures and activities to the achievement of company goals.
• Liaise with the clinical sites’ staff on an ongoing basis
• Create and implement study-specific clinical monitoring tools and documents.
• Coordinating and supervising clinical monitoring team.
• Provide Clinical Research Associates (CRA) and Clinical Research Coordinator (CRC) at sites with project-specific training and schedule regular meetings.
• Gathering and examining trial documents (Trial essential documents).
• Create clinical trials summaries in multiple formats, including spreadsheets, PowerPoint presentations, graphs and standard, written summaries and clinical report
• Prepare materials for submission to regulatory authorities (local/ central IRB, FDA, EC)

Qualifications

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field required
• A specialized certificate in clinical trials (CRA, GCP etc.)
• 5+ years of clinical trial experience for a medical device company with a minimum of 2 years of trial management experience.
• Knowledge in the statistical design concepts for designing a clinical study - advantage
• Experience conducting clinical studies that were submitted for FDA clearance
• A high degree of computer literacy and proficiency in the use of computer software such as Word, Excel, database applications PowerPoint, and e-communication software.
• Experience driving projects forward, whilst ensuring that relevant guidelines and regulations are adhered to, involving working within a team and delegating tasks appropriately.
• Strong understanding of GCPs, ICH, and knowledge of regulatory requirements.
• Fluent English. Additional languages - advantage.
• Psychiatric disorders Experience – Big advantage.