Study Start-Up Lead
Study Start-Up Lead
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Job Description
Band
Level 4Job Description Summary
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 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.Job Description
Key responsibilities:
Contributes SSU (Study Start-Up) insights to the Operational Execution Plan (OEP) and aligns the SSU strategy systems milestones and dashboards with the Study Leader and Clinical Trial Team (CTT).
Ensures correct trial-specific configuration of SSU systems (e.g. eTMF CTMS vendor tools budget/contract management tools translations ICF templates) to support trial operations effectively.
Prepares and leads the global SSU planning process and the SSU team (as a sub-team of the CTT) from kick-off through the completion of the SSU phase across all countries and sites.
Oversees global protocol/OEP amendments and document readiness (including vendor and IMP documentation) to ensure timely submission to health authorities and site activations.
Supports the Vendor Program Manager (VPM) for timely global vendor activation and coordinates investigator grant plans budget finalization and contract template readiness in line with protocol timelines.
Drives transparency for SSU deliverable timelines ensures TMF document quality for inspection readiness and manages risks with corrective actions to maintain startup timelines and quality.
Enables country SSU managers to execute start-up activities efficiently and provides oversight to ensure adherence to processes timely submissions and the use of tools/systems for site readiness.
Works with Global Clinical Supply (GCS) for clinical supply readiness ensures proper handoff to other roles and supports final global SSU deliverables for site initiation readiness and initial drug release.
Essential Requirements
Minimum 2 years experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
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
Proven ability to effectively engage and lead associates from varying backgrounds and functions within dispersed and highly matrixed organizations.
Excellent communication influencing and negotiating skills
Good knowledge of Good Clinical Practice clinical trial set-up design and global drug development process
Demonstrated effective influencing and negotiation skills at all levels.
Data and Digital expertise. Experience working with electronic databases clinical and/or project management planning and reporting and analytics systems
Data and timeline driven Willingness and ability to champion the use of new technology
Why Novartis Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. to Diversity & Inclusion: Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to receive more detailed information about the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities join the Novartis Network here: Desired
Budget Management Clinical Trials Negotiation Skills Process Improvement Project Planning Vendor Management Waterfall ModelEmployment Type
Full-Time
Key Skills
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