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.
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 Leadership and GICS.
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.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
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.
Perform quality control of documents provided by sites.
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, including local regulations, 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 experience working in regulatory and / or start-up departments.
Advanced English level