Regulatory & Start Up Specialist, Biotech, France

il y a 7 jours

Paris, Île-de-France IQVIA Temps plein

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

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