Regulatory and Start-up Specialist

2 weeks ago

Tel Aviv, Tel Aviv, Israel IQVIA Full time $60,000 - $80,000 per year

Job Profile Summary - Contractor Position

 Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.

• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.

• Prepare site regulatory documents, reviewing for completeness and accuracy.

• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.

• Review and provide feedback to management on site performance metrics.

• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.

• Inform team members of completion of regulatory and contractual documents for individual sites.

• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.

• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.

• Perform quality control of documents provided by sites.

• May have direct contact with sponsors on specific initiatives.

Qualifications

• High School Diploma or equivalent

• 5 year clinical research experience. Equivalent combination of education, training and experience.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more

  • Regulatory and Start-up Specialist

    2 weeks ago

    Tel Aviv, Tel Aviv, Israel IQVIA Full time $60,000 - $80,000 per year

    Job Profile Summary - Contractor PositionPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.Essential FunctionsUnder...

  • Study Start-Up Specialist

    1 week ago

    Tel Aviv, Tel Aviv, Israel BeOne Medicines Full time $104,000 - $130,878 per year

    BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General DescriptionResponsible for start-up activities...

  • Regulatory Affairs Specialist

    2 weeks ago

    Tel Aviv, Tel Aviv, Israel CustoMED Full time $90,000 - $120,000 per year

    The QA/RA Project Manager is responsible for Regulatory Affairs & Quality Assurance.Job Description:·       Lead compiling and preparing materials for submission to regulatory authorities.Lead Quality Management System (QMS) and medical device development and production, according to the project's scope and needs.·    Coordinate and document...

  • Director of Regulatory Affairs

    2 weeks ago

    Tel Aviv, Tel Aviv, Israel Nasus Pharma Full time $90,000 - $120,000 per year

    Nasus pharma is a clinical stage company developing powder-based Intranasal specialized product portfolio, to address acute medical conditions and public health threats.Nasus Pharma is seeking an experienced individual to lead the Regulatory Affairs (RA) function. In this position you will act as the primary contact for cross-functional product development...

  • Information Security Specialist

    2 weeks ago

    Tel Aviv, Tel Aviv, Israel Autofleet Full time ₪90,000 - ₪120,000 per year

    We are making the future of Mobility come to life starting today. At Autofleet we support the world's largest vehicle fleet operators and transportation providers to optimize existing operations and seamlessly launch new, dynamic business models - driving efficient operations and maximizing utilization.We are seeking a highly skilled and experienced...

  • Quality Assurance Compliance Specialist

    2 weeks ago

    Tel Aviv, Tel Aviv, Israel Aidoc Full time $90,000 - $120,000 per year

    Aidoc is recruiting an Quality Assurance Compliance Specialist in Tel Aviv. Join our teamAbout Aidoc:Aidoc is the market leader in Healthcare AI. We deliver the most widely used portfolio of AI solutions to help physicians prioritize life-threatening cases and improve patient outcomes. Aidoc's solutions are in use in over 1,000 hospitals, including the...

  • Global Talent Acquisition Specialist

    7 days ago

    Tel Aviv, Tel Aviv, Israel Titan Full time ₪104,000 - ₪130,878 per year

    Hello from TITAN We're a leading SaaS company specializing in seamless Salesforce and SAP integration. Our products redefine digital engagement on the Salesforce platform. We're on the lookout for a dynamic Global Talent Acquisition Specialist to join our team. If you're passionate about sourcing top talent and have a knack for top-notch technology, we want...

  • Global Talent Acquisition Specialist

    7 days ago

    Tel Aviv, Tel Aviv, Israel TITAN Full time ₪104,000 - ₪130,878 per year

    Hello from TITAN We're a leading SaaS company specializing in seamless Salesforce and SAP integration. Our products redefine digital engagement on the Salesforce platform. We're on the lookout for a dynamic Global Talent Acquisition Specialist to join our team. If you're passionate about sourcing top talent and have a knack for top-notch technology, we want...

  • Quality Assurance Compliance Specialist

    2 weeks ago

    Tel Aviv, Tel Aviv, Israel AIDOC Full time $90,000 - $120,000 per year

    About The PositionAidoc is recruiting an Quality Assurance Compliance Specialist in Tel Aviv. Join our teamAbout AidocAidoc is a pioneering force in clinical AI. Our clinical AI imaging solutions help physicians quickly identify and diagnose urgent cases and improve patient outcomes.Our solutions are being used daily in more than 1,000 hospitals, including...

  • Quality Assurance Compliance Specialist

    2 weeks ago

    Tel Aviv, Tel Aviv, Israel Aidoc Full time $90,000 - $120,000 per year

    Aidoc is recruiting an Quality Assurance Compliance Specialist in Tel Aviv. Join our team About AidocAidoc is a pioneering force in clinical AI. Our clinical AI imaging solutions help physicians quickly identify and diagnose urgent cases and improve patient outcomes. Our solutions are being used daily in more than 1,000 hospitals, including leading health...