Summary
About the Role
Senior Clinical Project Manager
Location – Hyderabad #LI Hybrid
About the Role:
Responsible for Clinical execution and management of all aspects of assigned clinical studies (interventional and non-interventional, from early phase to late phase) and other clinical services (e.g. managed access programs (MAP), Research Collaborations, IITs, Digital Solutions etc. driven by GBS on behalf of Novartis Organizations.
Key Responsibilities:
• Lead a global study team responsible for the planning and implementation of all operational aspects of scientifically and operationally sophisticated studies from study concept to clinical study report/manuscript writing, according to timelines, budget, operational and quality standards (ICH/GCP/SOPs and procedures).
• Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) in the effective planning, regular re-evaluation and implementation of assigned clinical studies and/or MAP/Research Collaborations/IITs/Digital Solutions programs according to Novartis Global processes ensuring adherence to timelines, budget, quality standards and operational procedures. Might be required to lead other projects/program, in collaboration with cross-functional teams.
• Accountable for investigators meeting organization and all internal meetings related to the clinical study execution and operational excellence.
• As applicable, directly Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution in alignment with Novartis global standard and local regulatory requirement.
• As applicable support compilation of study regulatory documents for submissions to competent authorities and ethics-committees in collaboration with other associated CONEXTS, Novartis line functions and CRO Partners as required. Also if needed support clinical studies with all onsite/remote monitoring activities and communications with investigators, investigational sites, clinical trial team, healthcare professional and other associated internal line-functions.
• In partnership with Clinical Operations Specialists (COS) (where applicable) accountable for the set up and maintenance of the Trial Master File (TMF), Clinical Trial Management.
• Responsible for working with CTT and QA to identify potential issues and implementing actions to resolve them. Where applicable oversee the work of assigned Clinical Project Manager(s), Clinical Operations Specialists(s), ensuring clear delegation /assignment of duties are documented.
• Lead innovation by identifying areas for process or technology improvements and participate in continuous improvement initiatives. Act as a mentor, including support the training and onboarding of new associates. Developing a continuous process of learning and reflection and solution-orientated approach. 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 teams representative of the patients and communities we serve.
Role Requirements :
Essential Requirements
• Relevant educational background in life sciences/Healthcare (Ideally a Bachelor’s Degree or above in life sciences) or equivalent combination of education, training and experience
• Approximately 10+ years of Clinical Operations experience with strong managerial experience in planning, driving, reporting and publishing clinical studies (interventional and non-interventional, early to late phase) in a pharmaceutical company or contract research organization.
• Proven ability to establish effective working relationship in a matrix and multicultural environment.
• Detailed knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.
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Desirable Requirements:
• Project management skills and experience a plus.
• Strong technical and organizational skills (Excel, MP).
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.
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
