Novartis
StudyStartUpAssociateDirector
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“Study Start Up Associate Director at Novartis. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, project management, clinical operations, clinical trials, global drug development process. Responsible for all Study Start-Up (SSU) activities for medium to highly complex high priority studies. Independent decision for all study start-up activities”
What You'll Achieve.
end‑to‑end study start‑up performance; balancing speed, quality, and risk across a complex global portfolio; deliver top‑quartile outcomes and readiness for future growth; timely global vendor activation; timely start-up activities from country allocation to “Ready to Enroll”; achieve start-up timelines and quality execution
What They're Looking For.
Must Have
Advanced degree or combination Bachelor’s Degree with equivalent experience, Minimum 6 years' experience in project management, in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials, Minimum 3 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, Comprehensive experience in leading multidisciplinary teams in a complex matrix environment, Demonstrated leadership driving high performing teams involving complex stakeholder management, Good knowledge of Good Clinical Practice, clinical trial set-up design and global drug development process
Nice to Have
A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management, is preferable
What You'll Do.
Responsible for all Study Start-Up (SSU) activities for medium to highly complex high priority studies
Independent decision for all study start-up activities
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 Trial Vendor Manager (TVM) as needed to ensure timely global vendor activation and HA submission documents
Drives transparency of timelines of global SSU deliverables with SSU Managers to ensure country alignment and efficiency
Global accountability of timelines
and quality of global TMF (Trial Master File) documents in study start-up to ensure TMF inspection readiness
Ensures 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
Coaches the country Study Start-up Managers to drive timely start-up activities from country allocation to “Ready to Enroll” within assigned medium to complex trials
May work as Study Start-Up Director deputy to lead SSU community and may provide mentorship/coaching to team member
How You'll Work.
Team & Collaboration
cross-functional coordination; vendor/stakeholder management; Proven ability to effectively engage and lead associates from varying backgrounds and functions within dispersed and highly matrixed organizations; Comprehensive experience in leading multidisciplinary teams in a complex matrix environment; Demonstrated leadership driving high performing teams involving complex stakeholder management
Process & Methodology
project management, Project Planning, Waterfall Model
Full Job Description
**Job Description Summary** The Study Start Up (SSU) Senior Lead is a strategic, enterprise-minded leader who drives end‑to‑end study start‑up performance, balancing speed, quality, and risk across a complex global portfolio. They influence at scale—shaping ways of working, aligning senior stakeholders, and empowering teams to deliver top‑quartile outcomes and readiness for future growth. **Job Description** Job posting title: Study Start Up Associate Director #LI-Hybrid Internal job title: SSU Senior Lead Location _:_ Barcelona Gran Via, Spain Job description Key responsibilities: * Responsible for all Study Start-Up (SSU) activities for medium to highly complex high priority studies. * Independent decision for all study start-up activities * 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 Trial Vendor Manager (TVM) as needed to ensure timely global vendor activation and HA submission documents * Drives transparency of timelines of global SSU deliverables with SSU Managers to ensure country alignment and efficiency * Global accountability of timelines, accuracy, and quality of global TMF (Trial Master File) documents in study start-up to ensure TMF inspection readiness * Ensures 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 * Coaches the country Study Start-up Managers to drive timely start-up activities from country allocation to “Ready to Enroll” within assigned medium to complex trials * May work as Study Start-Up Director deputy to lead SSU community and may provide mentorship/coaching to team member. **Essential Requirements:** * Advanced degree or combination
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