Niket K
Clinical Trial Submission Manager @ Tata Consultancy Services | CTIS, Regulatory Operations
- Role
- Clinical Trial Submission Manager Ctis & Eu Ctr Expert Regulatory Operations at Tata Consultancy Services
- Location
- Pune, IN
- LinkedIn followers
- 500 followers
About Niket K
Tata Consultancy Services empowers teams to navigate the complexities of clinical trial…
Experience
Clinical Trial Submission Manager Ctis & Eu Ctr Expert Regulatory Operations
Apr 2023 — Present · Pune, IN
Experienced Clinical Trial Submission Manager, leading and mentoring teams to drive regulatory submissions with precision, efficiency, and compliance. Passionate about process optimization, stakeholder collaboration, and Agile methodologies, ensuring seamless execution of clinical trial applications, modifications, and notifications through the EMA CTIS system.As a Subject Matter Expert in CTIS, I guide cross-functional teams, resolve regulatory submission challenges, and proactively implement automation strategies to enhance operational efficiency. I oversee the assembly of submission packages, regulatory documentation, and ensure accurate data input while maintaining real-time tracking systems.My role involves: Managing a team of specialists, fostering learning and continuous improvement in regulatory submission processes. Acting as the Single Point of Contact for EMA CTIS notifications, efficiently dispatching requests to cross-functional teams. Triaging and tracking Requests for Information from Health Authorities, ensuring compliance and timely responses. Supporting Sponsor High-Level Administrators with CTIS access and guiding teams on evolving submission requirements. Contributing to automation in eDMS for enhanced workflow efficiency, compliance, and risk management. Strengthening collaboration across local and functional organizations to drive seamless trial submissions across EU regions.I believe in continuous learning, adaptability, and proactive leadership, ensuring that every clinical trial submission is handled with integrity, efficiency, and a commitment to global healthcare advancements.
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