Regulatory & Start Up Specialist, IQVIA Biotech, France
il y a 4 heures
Regulatory & Start-Up Specialist 1 IQVIA Biotech France Homebased IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster. Job Overview 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 & Skills B Sc Degree in Life Sciences or related field 1 - 3 years’ clinical research experience Experience in regulatory submissions Experience in contract negotiations Position requires EU CTR experience for France, local language proficiency, and knowledge of national requirements. Certain submission tasks mandate a local address. French language proficiency is essential for direct communication with the Competent Authority and Ethics Committees. Good interpersonal communication and organizational skills. Good technology skills and knowledge of MS Office applications. Good attention to detail. General awareness clinical trial environment and drug development process. Ability to work on multiple projects. Ability to establish and maintain effective working relationships with co-workers, managers and sponsors. Ability to work independently, to problem-solve collaboratively and to raise issues appropriately as needed. 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 at https://jobs.iqvia.com #J-18808-Ljbffr
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Regulatory & Start Up Specialist, IQVIA Biotech, France
il y a 4 heures
Paris, France IQVIA LLC Temps pleinRegulatory & Start Up Specialist, IQVIA Biotech, France page is loaded## Regulatory & Start Up Specialist, IQVIA Biotech, Francelocations: Paris, Francetime type: Full timeposted on: Posted Todayjob requisition id: R1515222**Regulatory & Start-Up Specialist 1****IQVIA Biotech****France****Homebased**IQVIA Biotech partners exclusively with biotech and...
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Regulatory & Start Up Specialist, Biotech, France
il y a 7 jours
Paris, Île-de-France IQVIA Temps pleinRegulatory & Start-Up Specialist 1IQVIA BiotechFranceHomebasedIQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative...
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Regulatory & Start-Up Specialist – Site Activation (France)
Il y a 3 minutes
Paris, France IQVIA LLC Temps pleinA leading biotech company is seeking a Regulatory & Start Up Specialist in Paris. This role involves overseeing site activation activities, ensuring compliance with regulations, and managing communications with investigators and project teams. Candidates should have a Bachelor’s degree in Life Sciences, 1-3 years of clinical research experience, and...
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Regulatory & Start Up Specialist, French Speaker
il y a 7 jours
Paris, France Novasyte Temps pleinIQVIA MedTech Clinical Solutions, specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products.- IQVIA MedTech’s focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and...
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Clinical Research Associate
il y a 1 heure
Paris, France IQVIA LLC Temps pleinClinical Research Associate - IQVIA BIOTECH (homebased in France) page is loaded## Clinical Research Associate - IQVIA BIOTECH (homebased in France)locations: Paris, Francetime type: Full timeposted on: Posted Todayjob requisition id: R1482487Due to our continued growth, we are recruiting for a Sr. Clinical Research Associates to join our team. This...
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(Senior) Study Start-up Specialist
il y a 17 heures
Paris, France Precision Medicine Group Temps pleinPrecision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...
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Manager, Regulatory Affairs
il y a 2 semaines
Paris, Île-de-France IQVIA Temps pleinAbout IQVIAIQVIA is a global leader in healthcare intelligence, committed to defining and delivering the future of healthcare. Our brand stands for innovation, integrity, and impact—connecting data, technology, and expertise to improve outcomes for patients and partners worldwide. We foster a culture of collaboration, diversity, and continuous learning,...
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Manager, Regulatory Affairs
il y a 3 heures
Paris, France IQVIA Temps pleinAbout IQVIA IQVIA is a global leader in healthcare intelligence, committed to defining and delivering the future of healthcare. Our brand stands for innovation, integrity, and impact—connecting data, technology, and expertise to improve outcomes for patients and partners worldwide. We foster a culture of collaboration, diversity, and continuous learning,...
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Clinical Research Associate
il y a 2 semaines
Paris, Île-de-France IQVIA Temps pleinDue to our continued growth, we are recruiting for a Sr. Clinical Research Associates to join our team. This is a great opportunity for a CRA to join a progressive and developing CRO.IQVIA Biotech is unique division specialising in working with smaller biotech and emerging biopharma clients, and as such we have a vibrant, fast-paced working environment....
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Market Access and Public Affairs Specialist
il y a 4 heures
Paris, France IQVIA Temps pleinIQVIA is expanding its team and is seeking a Market Access and Public Affairs Specialist based in France. This is one of several newly created roles across the EU due to our customers’ ongoing success, and ahead of product launches in 2026. Our customer is a global biopharmaceutical company, dedicated to bringing biosimilar medicines to market, ensuring...
