Sponsor dedicated Job Location: Bucharest, Romania Job Location Type: Home-based Job Contract Type: Full time Job Seniority Level: 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 Plan
Configures and ensures proper trial-specific set-up of SSU systems
Prepares global SSU planning and leads SSU Team from kick-off through completion of SSU
Implements global aspects of protocol and OEP amendments, activates and oversees country implementation of amendments Global SSU Activation Leadership:
Ensures global trial templates are ready for country usage, global trial level document collected into eTMF, HA submissions done on time
Ensures timely global vendor activation
Directs 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 timelines
Provide proactive oversight and risk management for SSU team activities to achieve start-up timelines and quality execution, proposing and implementing corrective actions where appropriate Country SSU Accountability:
Posting details
Remote
Yes
Employment type
Full-time
Workplace type
Remote
Source
remotejobsorg
First seen
9/7/2026, 2:10:48 PM
Last seen
9/7/2026, 8:10:30 PM
Enables country Study Start-up Managers to drive timely start-up activities from country allocation to "Ready to Enroll" within assigned trial
Provides oversight and support to country Study Start-up Managers as needed to ensure that study start-up activities are conducted and completed to plan
Ensure 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 release
Ensures global and country budget processes and approvals support SSU activities and timelines Required background and expertise:
Bachelor's Degree in Life sciences or related field
6 years clinical research experience, including 3 years experience in a leadership capacity on a Global scale
Vendor management experience - knowledge of drug development process
Good regulatory and/or technical writing skills
High learning agility/problem solving, influencing/negotiation and problem- solving skills IQVIA 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 IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. This job is curated by Lifelancer. Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles.