Manager, Clinical Sciences

Location – Hyderabad #LI Hybrid

Major Responsibilities:

• Responsible and accountable for the operational planning and execution of IITs, RCs and NIS. Ensure Pre-MRC alignment and sit on US MRC as well as global SRC. Tracking and processing drug orders/re-supply and payments. Ensure key processes and documents are maintained/updated (e.g. TPSR, Pubs Review, TMF).
• Study closes out execution, including financial reconciliation, creating approval and closure letters, initiation of IND x-ref letter, and IN & IB distribution. Establish charters for and support management of SC and EO. Conduct Pre-RC alignment and Ensure EPRM and TPIAT (internal and external interface management).
• Compound drug forecasting/ review of drug packaging. Tracking and processing drug orders/re-supply and payments. Ensure key processes and documents are maintained/updated on time (e.g. TPSR, ICF Clinical Review, TMF). Study closes out execution, including financial reconciliation, creating approval and closure letters, initiate IND x-ref letter, and IN & IB distribution. Prepare for and support quarterly review meetings with TA teams
• Tracks and manages key trial milestones including monthly project status and key deliverables for management. Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems. Supports the development, management, and tracking of trial budgets working closely with the appropriate partners. And other activities as required based on business needs
• Tracks and manages key trial milestones including monthly project status and key deliverables for management. Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems. May Interface with the disease area and/or compound lead, global and US clinical team members, medical operations, trial operations, scientific operations, regulatory affairs, drug supply, data management, finance, quality, compliance, and other relevant functional areas
• Organizes and/or contributes to cross function meetings. Understands and complies with company SOPs and GCPs; contributes to continuous improvement in SOPs and local Working Practices. Supports planning of requirements for clinical trial (CT) material, ordering clinical trial material, setting up and monitoring the systems whereby material is shipped to the investigator, maintaining procedures to account for the CT material, checking the expiration of CT material and requesting extensions if necessary.
• Contributes to the review of clinical program documents assuring quality and consistency. Supports the development, management, and tracking of trial budgets working closely with the appropriate partners.
• Maintains project files including ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; all investigator and site correspondence; and schedules of payment.
• Responsible for maintenance of trial data in electronic Clinical Trial Management Systems (CTMS) and document management systems that support trial activities.

Minimum Requirements:

Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution.

Experience Required:

• Significant clinical research or research monitoring experience (comparable to 5 years) that provides the required knowledge, skills and abilities and experience mentoring or training others.
• In some cases, an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.

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
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.

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