Clinical Project Manager - IL

About Ibex:

IBEX develops state-of-the-art artificial intelligence solutions for cancer diagnostics. Our cutting-edge technology is transforming the diagnosis of cancer, leading to rapid and accurate decision making and providing new diagnostic insight to enable precision medicine.

IBEX is a well-funded start-up with global presence and headquarters in the USA and Israel.

Our world class team of researchers, engineers and medical experts is growing. If you are an outstanding professional, passionate about your work, a team player and want to make a difference in the lives of millions of people – Come join us!

Responsibilities:

• Manage global clinical trials and research, with focus on EU, responsible under VP Clinical & Scientific Affairs’ guidance, for all aspects of multiple clinical/research sites including protocols and support for regulatory documentation. 
• Collaborates across the company with multiple functions to ensure successful, rigorous and timely studies.
• Proactively manages clinical study processes: Oversees and supervises clinical operations, vendors/CROs and ensures that these activities are conducted in accordance with applicable regulatory requirements and guidelines including company SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards, as applicable.
• Ensures the identification, recruitment and selection of appropriate clinical sites & investigators and maintains strong relationships with external experts to ensure effective execution of clinical research projects.
• Develops and writes clinical study protocols and plans, IRB submission documents, CRFs and clinical study reports.
• Facilitates training to clinical study team per study protocol and supports regulatory submission and documentation.
• Contributes and implements all activities required for the generation of high-quality data deliverables on time and on budget (e.g., collaboration with statisticians and data managers, data overview, etc.).
• Analyzes data, interprets and presents results of clinical studies to internal and external stakeholders including participating in writing scientific abstracts and peer-reviewed publications.
• Occasional travel to clinical sites and conferences.

• MSc degree in life sciences, biomedical, biostatistics, or other related discipline; PhD – Significant Advantage
• GCP/CRA certified
• 4+ years of experience managing clinical development activities in medical device industry with at least 2+ years in Clinical Affairs. Previous experience in conducting medical device/IVD clinical studies – preferred
• Proven knowledge of medical device, IVD clinical development and oncology, FDA/CE and other applicable guidelines
• Prior experience with clinical development planning, regulatory requirements and documents, study design, biostatistics, monitoring, data handling, data analysis, report and manuscript writing
• Demonstrates a proven ability to both independently complete and lead peers in completion of complex plans, i.e., study protocols, selecting appropriate methodologies and evaluation tools
• In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data management, study report

*We are an equal opportunity employer and committed to creating a friendly, inclusive environment that is a pleasure to work in, and where there is an unbiased acceptance of others.