Study Start Up Senior Lead (Assoc Dir)

Job Description Summary

The Study Start-Up (SSU) Senior Lead independently leads the planning and execution of global SSU activities for multiple medium to complex global studies of high priority, 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 Senior Lead works collaboratively with other key CTT members and leads the SSU Team (CTT sub-team / 20+ members across multiple countries) 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.

 

Job Description

Internal Job Title: Study Start-Up Senior Lead (Level 5/GJFA 4)

Position Location: The ideal location for this role is the East Hanover, NJ site, but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to East Hanover, NJ site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.

The Study Start-Up (SSU) Senior Lead independently leads the planning and execution of global SSU activities for multiple to complex global studies of high priority, 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 Senior Lead works collaboratively with other key CTT members and leads the SSU Team (CTT sub-team / 20+ members across multiple countries) 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.

 Key Responsibilities:

•    Responsible for all Study Start-Up (SSU) activities for medium to highly complex high priority studies. 
•    Independent decisions for all study start-up activities. 
•    Full responsibility to independently deliver 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.) 
•    Autonomously strategizes 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) 
•    Implements global aspects of protocol and OEP amendments, activates and oversees country implementation of amendments as determined per trial and in conjunction with Study Leader. 

 Leads Global SSU Activation: 

•    Responsible for 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 
•    Guides 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 
•    Drives transparency of timelines of global SSU deliverables with SSU Managers to ensure country alignment and efficiency 
•    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 
•    Ensure 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 
•    Collaborates with GCS (Global Clinical Supply) to ensure coordination and readiness of global clinical supply 
•    Ensures the use and date completeness/accuracy of