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 Clinical Trial Team (CTT) members and leads the SSU Team (CTT sub-team) comprised of the country SSU Management, Vendor Management, Regulatory, Grants and Contracts, Translations, Document Management, Clinical Supplies, and others as needed to accelerate study, country, and site activation.
About the Role
Key Responsibilities:
Early Planning and Team Leadership:
1. 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.)
2. 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:
1. 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
2. Drives transparency of timelines of global SSU deliverables with SSU Managers to ensure country alignment and efficiency
3. Global accountability of timelines, accuracy, and quality of global TMF (Trial Master File) documents in study start-up to ensure TMF inspection readiness
4. 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 Novartis standards and local and international regulations
5. Collaborates with GCS (Global Clinical Supply) to ensure coordination and readiness of global clinical supply
Accountable for country SSU:
1. 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 and usage of tools/systems, timely delivery of SSU deliverables (e.g. IRB/IEC submission packages, Informed Consent review, local submission package for submission to IRB/IEC, CTA (Clinical Trial Application) Hub (Europe: acc. to new EU-CTR) as well as Health Authorities and adherence to process standards.
2. Supports the VPM as needed to ensure global vendor activation and site readiness in collaboration with to meet site activation timelines/plan.
Key Performance Indicators:
1. High quality, timely SSU deliverables/documentation/data in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP (Standard Operation Procedure) requirements
2. Advanced degree or combination Bachelor’s Degree with equivalent experience. A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management, is preferable
3. Fluent English, spoken and written
4. Minimum 2 years' experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
5. Minimum 1 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization
6. Proven ability to effectively engage and lead associates from varying backgrounds and functions within dispersed and highly matrixed organizations.
7. Good knowledge of Good Clinical Practice, clinical trial set-up design and global drug development process
8. Data and Digital expertise. Experience working with electronic databases, clinical and/or project management planning and reporting and analytics systems
9. Data and timeline driven, Willingness and ability to champion the use of new technology
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