Study Start-Up Lead

Location: UK, Spain, Poland, Bulgaria, Netherlands (fully homebased)

Fully sponsor dedicated

As a Study Start Up Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Working fully embedded within a growing, top 5 Pharmaceutical company, you will be responsbile for executing 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.

What you will be doing:

Early Planning and Team Leadership:

• Contributes SSU insights to the development of the trial Operational Execution Plan (OEP) and aligns the SSU plan and strategy accordingly as reflected in SSU systems, milestones and dashboards with Study Leader/Clinical Trial Team (CTT).
• Configures and ensures proper trial-specific set-up of SSU systems (e.g., Expected Document Lists, eTMF, milestones, tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS (Clinical Trial Management System), enrollment plan, vendor management tool, site contracting and budgeting tool, ICF template tool, etc.).
• Prepares global SSU planning and leads SSU Team (CTT sub-team) from kick-off through completion of SSU (all countries and 95% sites enrolling or as defined per trial).

Leads Global SSU Activation:

• Ensures timely collection global trial level document readiness (including vendor and IMP (INVESTIGATIONAL MEDICINAL PRODUCT)) and collection into eTMF as necessary for country health authority and Ethics Committee submission and site activation.
• Supports the Vendor Program Manager (VPM) as needed to ensure timely global vendor activation and HA submission documents.
• Ensures Protocol and ICF (Informed Consent Form) global trial template is ready for country usage as necessary including translations.
• 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.
• Global accountability of timelines, accuracy, and quality of global TMF (Trial Master File) documents in study start-up to ensure TMF inspection readiness.
• 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, according to our clients standards and local and international regulations.
• Collaborates with GCS (Global Clinical Supply) to ensure coordination and readiness of global clinical supply.
• 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, including set-up