Study Start Up Lead, Novartis dedicated

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:

• 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 or equivalent combination of education, training and experience

• Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process

• Demonstrated proficiency in using systems and technology to achieve work objectives

• Good regulatory and/or technical writing skills

• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines

• High learning agility/problem solving, influencing/negotiation and problem- solving skills

• Tech Sawy, championing innovative technology platforms