Regulatory and Start Up Specialist

IQVIA; France; Hybride; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A global consulting firm is seeking a Site Activation Manager to perform tasks associated with site activation activities in compliance with applicable regulations. The role requires a Bachelor’s Degree in life sciences and 3 years of relevant experience. The position is hybrid, requiring office visits in Paris three times a week, and fluency in French is mandatory.

Qualifications

• 3 years of clinical research or relevant experience required.
• Must have knowledge of regulatory requirements and company standards.
• Understanding of the drug development process is essential.

Responsabilités

• Serve as Single Point of Contact for assigned studies.
• Ensure adherence to standard operating procedures and timelines.
• Perform start-up and site activation activities.

Connaissances

Knowledge of GCP/ICH guidelines

In-depth knowledge of clinical systems

Ability to apply regulatory guidelines

Strong communication skills in French

Formation

Bachelor’s Degree in life sciences

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.

Hybrid role as office visits in Paris will be required 3 x a week. French language fluency required.

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

Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.

• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process.