IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
We are recruiting to fill the position below:
Job Title:Senior Site Activation Specialist
Location: Lagos
Employment Type: Full-time
Job Overview
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 the effectiveness of the job area.
Responsibilities
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 them for completeness and accuracy
Review, track and follow up on the progress, 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 ongoing 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.
Requirements
Bachelor’s Degree in Life Science or related field
Minimum 3 years prior experience in life sciences or similar. Experience in a leadership capacity is considered advantageous
Fluent/ native language capabilities, including English
Makes recommendations for enhancements in systems and processes to solve problems or improve the effectiveness of job area
Good negotiating and communication skills with the ability to challenge
Makes recommendations for enhancements in systems and processes to solve problems or improve the 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.