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Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management:

Job Category:

Professional

All Job Posting Locations:

Caesarea, Haifa District, Israel

Job Description:

Johnson & Johnson Med Tech is seeking a highly motivated and experienced Clinical Trial Manager (CTM) to lead and oversee clinical study operations across Israel and Europe. This role is responsible for ensuring end‑to‑end execution of clinical trials in alignment with ICH-GCP, regulatory requirements, and company SOPs.

About the Role

As a Clinical Trial Manager, you will drive the operational excellence of our clinical studies—from protocol development through site activation, enrollment, monitoring, and study close‑out. You will collaborate extensively with cross‑functional partners, global teams, clinical sites, and external vendors to ensure high-quality study execution, on time and within budget.

Key Responsibilities

• Lead and manage all operational aspects of assigned clinical studies.
• Develop and maintain essential study documents including protocols, informed consent forms, source documents, training materials, and more.
• Own key study deliverables: training, site activation and management, patient enrollment, compliance, study close‑out, and support of regulatory submissions.
• Collaborate with cross‑functional teams to ensure study activities meet timelines and quality goals.
• Identify study risks and implement proactive mitigation strategies.
• Participate in and lead process improvement initiatives, including SOP creation and optimization.
• Partner with global clinical teams and cross-functional stakeholders.
• Review regulatory documents to ensure compliance with GCP and study requirements.
• Maintain strong relationships with investigators and site coordinators; conduct site visits to support enrollment and ensure adherence to protocol.
• Drive patient recruitment and ensure timely study completion.
• Manage investigational product accountability and reconciliation.
• Negotiate and manage Clinical Trial Agreements (CTAs) and study budgets.
• Oversee CROs and vendors, including performance monitoring and visit report review.
• Track internal and external project deliverables to ensure alignment with budget and timelines.
• Stay current with relevant regulations, guidelines, and company procedures.
• Perform additional tasks as needed to support successful study execution.
• Advantage: Knowledge of local regulatory pathways in Israel and the EU (MoH, EC submissions/approvals).

Required Experience & Qualifications

Education & Experience

• Bachelor’s degree (or higher) in a scientific or related discipline.
• Minimum 5 years of clinical trial management experience in Pharma, Biotech, or CRO.
• Experience managing multi-center and international clinical studies (preferred).

Knowledge, Skills & Abilities

• Fluency in written and spoken English.
• Strong understanding of ICH-GCP and global clinical research regulations.
• Proven ability to work effectively in both corporate and smaller, agile team environments.
• Hands-on approach with exceptional organizational skills and attention to detail.
• Excellent communication and interpersonal skills; ability to build strong partnerships internally and externally.
• Proficiency with Microsoft Office, Adobe, Docu Sign, and commonly used clinical systems (EDC, IRT, eTMF, EMR).

Required Skills:

Preferred Skills:

Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)