Study Start-Up Senior Lead
Company: Novartis
Location: Hyderabad, India (Office-based)
Job Type: Full-time | Permanent
Experience Required: Minimum 6+ years in clinical operations / study start-up / project management (global clinical trials experience required)
Novartis is seeking an experienced Study Start-Up Senior Lead to independently lead global study start-up activities across multiple complex clinical trials. This role is responsible for driving end-to-end study activation strategy, ensuring timely site initiation, regulatory submissions, and readiness for patient enrollment across global regions.
The position plays a critical leadership role within clinical trial operations, coordinating cross-functional teams and ensuring all study start-up deliverables meet regulatory, quality, and timeline expectations.
Global Study Start-Up Leadership
Lead planning and execution of global study start-up (SSU) activities for medium to highly complex clinical trials
Develop and execute study start-up strategy aligned with operational execution plans (OEP)
Ensure timely completion of all SSU milestones from trial initiation to site activation
Configure SSU systems including CTMS, eTMF, vendor tools, and enrollment tracking systems
Regulatory & Site Activation Management
Oversee preparation and submission of regulatory and ethics documentation (HA/IRB/IEC)
Ensure readiness of informed consent forms, protocol documents, and submission packages
Drive country-level site activation and ensure alignment with global timelines
Manage trial master file (TMF) readiness and inspection preparedness
Cross-Functional Coordination
Lead SSU sub-teams across multiple countries including regulatory, vendor management, contracts, translations, and clinical supplies
Collaborate with clinical trial teams, global clinical supply, and vendor partners
Ensure alignment between SSU strategy and global clinical development plans
Vendor & Budget Oversight
Oversee vendor activation and ensure timely delivery of SSU-related services
Manage investigator grants, site budgets, and contract readiness in alignment with trial timelines
Monitor and control SSU-related financial and operational processes
Risk & Quality Management
Identify risks impacting study start-up timelines and implement corrective actions
Ensure compliance with global regulatory standards and internal SOPs
Maintain high-quality execution across all SSU deliverables
Team Leadership & Coaching
Lead and mentor country-level study start-up managers
Provide guidance on systems, processes, and regulatory requirements
Drive performance across a large, multi-country matrix team
Strong expertise in clinical trial study start-up and clinical operations
Deep understanding of global regulatory submissions (IRB/IEC/HA processes)
Experience working with CTMS, eTMF, and clinical trial systems
Strong project management and cross-functional leadership skills
Ability to manage large, distributed, and matrixed teams
Knowledge of clinical trial budgeting, contracts, and vendor management
Strong communication, planning, and organizational skills
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline is required
Advanced degree (Master’s or equivalent) is preferred
Minimum 6+ years of experience in clinical operations or project management
At least 3 years of hands-on experience in clinical trial execution and planning in a global pharmaceutical or CRO environment
Proven experience leading study start-up or clinical trial activation activities
Experience working in large, complex, global matrix organizations is required
Clinical Study Start-Up (SSU) Strategy
Regulatory & Ethics Submissions
Site Activation & Trial Readiness
Vendor & Budget Management
Clinical Trial Operations Leadership
Global Project Coordination
Novartis is a global leader in innovative medicines, dedicated to transforming clinical research and drug development. The organization focuses on accelerating clinical trial execution through advanced processes, digital systems, and globally integrated operational excellence.
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