Study Start Up Associate Director

About this role

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.

Requirements

• 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
• Desirable Requirements:
• A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management, is preferable
• Commitment to Diversity and Inclusion:
• Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
• Skills Desired
• Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model