The Study Start-Up (SSU) Lead plans and executes global SSU activities to ensure timely trial document and task completion to enable country HA (Health Authorities) and Ethics Committee submissions and site activation to meet ambitious recruitment plans.
The Study Start-Up Lead works collaboratively with other key team members and leads the SSU Team as needed to accelerate study, country, and site activation.
Key accountabilities:
Early Planning and Team Leadership:
Contributes SSU insights to the development of the trial Operational Execution PlanConfigures and ensures proper trial-specific set-up of SSU systemsPrepares global SSU planning and leads SSU Team from kick-off through completion of SSUImplements global aspects of protocol and OEP amendments, activates and oversees country implementation of amendmentsGlobal SSU Activation Leadership:
Ensures global trial templates are ready for country usage, global trial level document collected into eTMF, HA submissions done on timeEnsures timely global vendor activationDirects the Study Grants Expert for investigator grant plan/fair market value assessment initiation and finalization of country site budget and contract template readiness in conjunction with protocol timelinesProvide proactive oversight and risk management for SSU team activities to achieve start-up timelines and quality execution, proposing and implementing corrective actions where appropriateCountry SSU Accountability:
Enables country Study Start-up Managers to drive timely start-up activities from country allocation to "Ready to Enroll" within assigned trialProvides oversight and support to country Study Start-up Managers as needed to ensure that study start-up activities are conducted and completed to planEnsure global vendor activation and site readiness in collaboration with to meet site activation timelines/plan.Ensure global deliverables to enable site initiation readiness is in place for initial drug releaseEnsures global and country budget processes and approvals support SSU activities and timelinesRequired background and expertise:
Bachelor's Degree in Life sciences or related field6 years clinical research experience, including 3 years experience in a leadership capacity or equivalent combination of education, training and experienceThorough understanding of regulated clinical trial environment and in depth knowledge of drug development processDemonstrated proficiency in using systems and technology to achieve work objectivesGood regulatory and/or technical writing skillsStrong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelinesHigh learning agility/problem solving, influencing/negotiation and problem- solving skillsTech Sawy, championing innovative technology platformsIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
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