Allucent

QA Engineer

• Lead, identify, develop and implement the business strategy for the Quality department
• Develop and agree upon operating procedures and business processes
• Lead executive and senior management team meetings
• Review audit reports, including process, project and vendor audits, as applicable
• Maintain and develop organizational culture, values and reputation
• Report to applicable internal stakeholders on business strategy, planning, results and performance for the Quality department
• Support regulatory authority inspections as needed
• Represent the Quality organization in key meetings, including Monthly Business Reviews and Board meetings
• Monitor and assure client satisfaction on existing Quality department projects
• Identify key accounts and maintain strong, long-lasting relationships to win new and repeat business
• Lead the strategic vision, operations and financial health of the Quality organization
• Oversee planning, preparation and execution of customer audits and inspections
• Lead approaches for quality KPIs and metrics in accordance with SOPs, regulatory guidelines, executed client contracts and client expectations
• Participate in the Allucent Leadership team

VP – Quality Assurance

Associate

• Track relevant information, data, progress, and milestones in CTMS and/or other tracking tools for assigned Start-Up activities.
• Ensure planned dates are reliable and up to date in CTMS departments/study teams.
• File document-owner documents in the (e)TMF and assist other Study Start-up team members with filing.
• Prepare, compile, submit, and maintain regulatory documentation for local clinical-trial regulatory agencies.
• Provide documents compliant with local regulations and support review of technical, pre-clinical, and clinical reports for regulatory submissions.
• Interact with regulatory authorities; prepare and submit responses to agency questions.
• Monitor updates to regulations, guidelines, and procedures and communicate them as appropriate.
• Support the Global Regulatory Manager and/or Global Submission Specialist as needed.
• Prepare, compile, submit, and maintain local IEC/IRB ethical requirements and documentation.
• Interact with IEC/IRB and prepare and submit responses to questions.
• Adapt country SIS/ISF to site-specific requirements.
• Provide country-specific requirements affecting site-contract processes.
• Prepare, review, negotiate, and finalize CTAs, LOIs, termination letters, budgets, and other site-level agreements.
• Communicate contract status with sites and internal personnel; arrange translations where applicable.
• Obtain site and Sponsor/Allucent signatures as applicable.
• Prepare site-specific Essential Document Packages and send them to sites.
• Collect and conduct first review of Essential Documents; follow up on discrepancies until resolution.
• Obtain authorization for shipment of Investigational Product to sites.
• Track relevant information and data in CTMS and/or other tracking tools.

Start-Up Associate II

• Coordinate and perform local site start-up activities for clinical studies.
• Track start-up information, data, progress, milestones, and planned dates in CTMS and/or other tracking tools.
• File and assist with filing documents in the (e)TMF.
• Prepare, compile, submit, and maintain regulatory documentation for local clinical-trial authorities.
• Provide compliant documents and support review of technical, pre-clinical, and clinical reports.
• Interact with regulatory authorities and prepare responses to agency questions.
• Monitor regulatory updates and communicate changes to relevant stakeholders.
• Prepare, submit, and maintain ethical documentation for IEC/IRB requirements.
• Interact with IEC/IRB and prepare responses to questions.
• Adapt country SIS/ISF to site-specific requirements.
• Provide country-specific requirements affecting site-contract processes.
• Prepare, review, negotiate, and finalize CTAs, LOIs, termination letters, budgets, and other site-level agreements.
• Communicate contract status with sites and internal personnel.
• Arrange translations and obtain required site and Sponsor/Allucent signatures.
• Prepare site-specific Essential Document Packages and send them to sites.
• Collect and initially review Essential Documents and resolve discrepancies.
• Obtain authorization for shipment of Investigational Product to sites.
• Track relevant information and data in CTMS or other tracking tools.

Start-Up Associate Contractor

• Lead, identify, develop, and implement the business strategy for the Quality department
• Develop and agree upon operating procedures and business processes
• Head executive and senior management team meetings
• Review audit reports, including process, project, and vendor audits, as applicable
• Maintain and develop organizational culture, values, and reputation
• Report to applicable internal stakeholders on business strategy, planning, results, and performance for the Quality department
• Support regulatory authority inspections as needed
• Represent the Quality organization in key meetings, including Monthly Business Reviews and Board meetings
• Monitor and assure client satisfaction on existing Quality department projects
• Identify key accounts and maintain strong long-lasting relationships to win new and repeat business
• Lead the strategic vision, operations, and financial health of the Quality organization
• Oversee planning, preparation, and execution of customer audits and inspections
• Lead approaches for quality KPIs and metrics in accordance with SOPs, regulatory guidelines, executed client contracts, and client expectations
• Take part in the Allucent Leadership team

VP, Quality Assurance

Clinical Research

• Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits
• Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements
• Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection
• Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety
• Perform activities around regulatory affairs, site activation, and study startup
• Own investigator-site relationships and serve as a bridge between sponsor and site
• Travel throughout Israel

Senior Clinical Research Associate – Contractor

Project Manager

• Lead cross-functional teams to deliver clinical trials on time, within scope, and on budget
• Develop and execute project plans aligned with GCP, SOPs, and regulatory standards
• Serve as the primary point of contact for sponsors, vendors, and internal teams
• Select, manage, and oversee vendors strategically
• Proactively address challenges, scope changes, risks, and resource allocation
• Lead key meetings and ensure Trial Master File and study records are complete and inspection-ready
• Drive global clinical trials from study start-up through final delivery
• Oversee cross-functional teams to ensure studies remain on track, on budget, and compliant with GCP and regulatory requirements

Senior Project Manager, Global Project Leadership

• Produce and oversee recommendations for country and site selection strategies, enrolment projections, and subject recruitment strategies
• Ensure the integrity and proper interpretation of data sources and resulting feasibility strategies and reports
• Support Business Development and Allucent Centers of Expertise
• Provide input to proposals and business development, including project assumptions, budgets, timelines, countries, sites, and projected patients
• Identify disease-prominent regions and develop initial country pools
• Identify disease or syndrome incidence and prevalence
• Analyze competing clinical trial landscapes to assess feasibility and enrollment barriers
• Access open-source and proprietary databases to assess similar patient populations and therapeutic classes
• Determine comparator drug access and reimbursement in proposed countries
• Present Allucent’s global or regional expertise and study footprint
• Present and explain feasibility analyses to BD and clients, including during bid defense meetings
• Maintain internal feasibility libraries and databases
• Interface effectively with Centers of Expertise and Business Development teams
• Maintain current knowledge of relevant guidelines and technologies
• Report to the GSSU, Site & Patient Engagement department