Regulatory & Start Up Specialist I, IQVIA MedTech, France

QFR IQVIA RDS France; Courbevoie; Sur place; EUR 40 000 - 55 000; Plein temps

Résumé du poste

A leading clinical research organization in Courbevoie seeks a Site Activation Specialist. You will manage site activation activities, ensure compliance with regulations, and serve as a point of contact for investigative sites. The ideal candidate will have a B Sc in Life Sciences and 1-3 years of clinical research experience, with proficiency in French. This role requires strong communication skills and attention to detail.

Qualifications

• 1 - 3 years’ clinical research experience.
• General awareness of clinical trial environment and drug development process.
• Ability to establish and maintain effective working relationships.

Responsabilités

• Serve as Single Point of Contact (SPOC) in assigned studies.
• Ensure adherence to standard operating procedures (SOPs).
• Perform start-up and site activation activities according to regulations.

Connaissances

French language proficiency

Good interpersonal communication

Organizational skills

Attention to detail

Ability to work on multiple projects

Formation

B Sc Degree in Life Sciences or related field

Outils

MS Office applications

Description du poste

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

• B Sc Degree in Life Sciences or related field

• 1 - 3 years’ clinical research experience

• 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.