Perform tasks at a country level associated with Site Activation (SA) activities
Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments
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.

Bachelor’s Degree in life sciences or a related field
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
Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Regulatory and Start Up Specialist

Key skills