AddressJob Description Summary
Senior Study Start Up Lead, Location: Ireland, UK, Hyderabad, #LI-RemoteAbout the role:
The Senior 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 Clinical Trial Team (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 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
• Configures and ensures proper trial-specific set-up of SSU systems (e.g., Expected Document Lists, electronic Trial Master File (eTMF), milestones, tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS (Clinical Trial Management System), enrolment plan, vendor management tool, site contracting and budgeting tool, ICF (Informed Consent Form) template tool, etc.)
• Ensures timely collection 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
• Ensures Protocol and ICF global trial template is ready for country usage as necessary including translations
• Global accountability of timelines, accuracy, and quality of global TMF (Trial Master File) documents in Study Start-up to ensure TMF inspection readiness
• 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, according to Novartis standards and local and international regulations
• Collaborates with GCS (Global Clinical Supply) to ensure coordination and readiness of global clinical supply
• Enables country Study Start-up Managers to drive timely start-up activities from country allocation to “Ready to Enrol” within assigned trial
Key Performance Indicators:
• Consistent, data driven SSU process delivery to plan at or above 25th percentile of KMR cycle times (6-month reduction of FP(First Patient) to LPFV (Last Patient First Visit))
• High quality, timely SSU deliverables/documentation/data in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and Standard Operation Procedure requirements
• Timely, efficient and quality execution of trials and trial related activities within assigned clinical program(s) within budget, and in compliance with quality standards.
Essential Requirements:
• A degree in scientific or health discipline required and an advanced degree with clinical trial experience and/or project management
• Fluent English, oral and written
• Experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
• 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
• Data and Digital expertise. Experience working with electronic databases, clinical and/or project management planning and reporting and analytics systems
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s 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:
https://www.novartis.com/about/strategy/people-and-culture
You’ll receive
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
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.
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: https://talentnetwork.novartis.com/network
Skills Desired
Budget Management, Clinical Trials, Negotiation, People Management, Process Improvements, Project Management, Project Planning, Vendor Management
