Maintains up to date knowledge, ensures adherence and compliance with local regulatory requirements and associated documents
Ensures all start up information & requirements are kept up to date in a central repository for project teams
Registration of Company studies, conducted in Israel, in the Israeli Ministry of health (MoH) mytrial website
Works in close collaboration with the study Clinical Project Manager (CPM) and the assigned Regulatory representative for the study, provides status updates on an ongoing basis, escalates when required
May assist with the translation and co-ordination of translations for documents required for submission
Contributes to the study start-up activities including local adaptation of study master ICF(s)
May be delegated to act as the primary contact with investigative sites during site start-up activities
May support in the collection and distribution of documents from / to sites
Ensures all essential documents are reviewed in accordance to local regulations and SOP
Prepares Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents
Responsible to prepare and submit EC and MoH (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
Tracks metrics and study start-up timelines to identify trends and opportunities for improvement
Interacts with multiple cross-functional teams to facilitate and assist in obtaining and compiling response letters to the ECs or MoH
Tracks and prepares for submission, throughout study duration, on an ongoing basis per local regulatory requirements
Participates and provides status updates during weekly study team meetings
Collaborate with TMF on regulatory submitted docs
Identifies, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment estimation or strategy and study non-compliance
Keeps up to date with evolving regulation in collaboration with Regulatory and Legal
May actively support MoH inspection and pre-inspection activities
May support audit preparation & Corrective Action and Preventative Action (CAPA) preparation for local related issues.
Requirements: Bachelors degree or nursing qualification is required. Scientific/health care field preferred
Minimum 4 years of experience in preparation, tracking and submission of studies involving investigative product, to Israeli ECs and MoH, at CRO, Sponsor pharmaceuticals companies
Familiar with the various local ECs requirements and submission processes
Excellent knowledge of the Israeli Ministry of health Guidelines and requirements, for Investigative product, genetic and advanced therapy study submissions
Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation
Adequate ICH-GCP knowledge
Requires strong attention to detail in composing and proofing materials
Able to establish priorities and meeting tight deadlines
Pro-active and problem-solving attitude
Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands with flexibility
Self-motivation, able to take initiative and work independently with minimal supervision
Able to proactively seek guidance when necessary
Team player, collaborative attitude, able to work with cross-functional teams
Excellent planning and organizational skills
Personal resilience, perseverance, energy and drive
Excellent written and verbal English and Hebrew communication skills
Must be able to professionally interact and communicate with both internal and external professional groups.
המשרה מיועדת לנשים ולגברים כאחד.