Our Senior Site Activation Specialists 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. You may also be involved in maintenance activities

You are expected to be a developing professional who works under moderate oversight and supervision and is responsible for making recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area.

• 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 feasibility, site ID, 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 documents, reviewing for completeness and accuracy
• Review, track and follow up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines
• 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 feasibility, site ID, regulatory and contractual documents for individual sites
• 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
• Standard CSA activities across SSA countries
• In country contact with the regulator
• Engage with sponsors during start-up as needed
• Gathering of regulatory intelligence
• Maintenance activities

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor’s Degree in Life Science or related field
• Minimum 3 years’ prior experience in life sciences or similar. Experience in a leadership capacity considered advantageous
• Fluent/ native language capabilities, including English
• Makes recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area
• Good negotiating and communication skills with ability to challenge
• Makes recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area
• Ability to handle change and ambiguity
• Ability to work on multiple projects
• Applicants will ideally have knowledge of applicable functional/regulatory requirements, including local regulations, SOPs and GCP/ICH