Summary
About the Role
Clinical Operations Specialist
Location – Hyderabad #LI Hybrid
About the Role:
Responsible to complete clinical services and meet planned deliverables in line with defined roles and responsibilities agreed with colleagues/customers.
Key Responsibilities:
Support set-up and maintenance of information in Clinical Trial Management Systems (CTMS) and other systems as applicable, under responsibility of COS or CPM as applicable: Update data, timelines, landmarks, EC/HA authorizations, etc. on an ongoing basis.
Support (Sr.) Clinical Project Manager (CPM) with study budget management, ensuring accurate planning, tracking and reporting of clinical study budget and Grant Plan as applicable. Perform Good receipt booking in line with Vendor financial report and study status, as required
Support set-up and maintenance of Trial Master File (TMF): Ensuring that all key documents are present and filed as appropriate in TMF, under responsibility of COS or CPM as applicable. Follow up with Clinical Trial Team at agreed frequency for TMF maintenance.
Track clinical service progress, ensure CTMS, TMF and other systems as applicable are up to date, report to colleague/customer as per scope of work. Address questions; escalate issues or critical findings to project lead (Sr./CPM).
Support (Sr.) CPM in set up and coordination of External Service Providers, ensuring all information, documentation and material in place for study start during study conduct and close-out. Follow-up with External Service Providers on day-to-day operations.
Ensure all data is reported to the Clinical Trial Team and available to colleague/customer. Logistical support to study team (internal and external) onboarding process
Support in meeting set up, coordination and meeting minutes, running reports from systems, draft project documentation. Support CTT in study start-up activities, recruitment and close-out activities as required. Champion the implementation of operational changes and transitions as required.
Commitment to Diversity & Inclusion: :
We are committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Essential Requirements
Approximately 3-4 years of operational experience of clinical study execution in a pharmaceutical company or contract research organization.
Experience in finance: forecast, actuals, cost reconciliation, a plus. Strong technical and organizational skills (Excel, MP,), Details oriented.
Desirable Requirements:
• Thorough knowledge of Good Clinical practice. Proven ability to establish effective working relationship in a matrix and multicultural environment.
• Demonstrated presentation and diplomacy skills. Strong customer focused mindset.
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. https://www.novartis.com/careers/benefits-rewards
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
