RSU Specialist - fixed-term contract (6 months) - France

Description de l'offre

PURPOSE
Perform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May participate in feasibility and/or site identification activities.

RESPONSIBILITIES
· Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU
· Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to
· standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project
· timelines.
· Perform Regulatory, Start-up and Maintenance 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.
· Review, prepare and negotiate site contracts and budgets with sites.
· 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, including contracts, regulatory,
· ethics ICF and IP Release documents, in line with project timelines.
· Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
· Perform quality control of documents provided by sites.
· May have direct contact with sponsors on specific initiatives.
· May perform Site Selection Visits if a trained monitor.
· May participate in feasibility and/or site identification activities.

Profil recherché

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
·  In-depth knowledge of clinical systems, procedures, and corporate standards
·  Effective communication, organizational, planning and interpersonal skills
·  Ability to work independently and to effectively prioritize tasks
·  Ability to work on multiple projects
·  Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
·  Knowledge of applicable regulatory requirements, SOPs and company's Corporate Standards
·  Understanding of regulated clinical trial environment and knowledge of drug development process
·  Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's Degree in life sciences or a related field and 1 year‘s clinical research or other relevant experience; or equivalent combination of education, training and experience. Fluent French and English language skills.