Clinical Trial Supply Manager

Year    India, India

Job Description


2025! This is the year that Global Clinical supply is targeting for completing the evolution our systems into a \'digital enabled\' landscape of 300+ associates. Join a team of globally collaborative colleagues at the \'Global Clinical Supply (GCS)\' function to support clinical trials from Phase 1 to approval and be a key interface between Technical Research & Development (TRD) teams and the Clinical teams! At GCS, we aspire to become a data and digital powered, resourceful , agile organization to deliver more products to more patients efficiently, through empowered and highly capable teams. Your responsibilities include, but are not limited to: . Represents GCS as a core member in the integrated Clinical Trial Team (iCTT) defines and advises the iCTT on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency and risk management. . Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule. . Creates and maintains complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate overage and by using defined processes and systems. . Creates and drives finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial. . Defines clinical supply parameters for NIRT set up and initiates subsequent updates throughout the duration of the clinical trial . Develops and executes a trial-level project plan together with all other relevant roles. Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity . Collaborates with all relevant line function partners for country submission and approval timelines (including IND-IMPD amendment) to develop optimal supply strategy. . Generates optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions. Triggers and tracks shipments of IMPs from central depot to regional hubs and local depots. Diversity & Inclusion / EEO Minimum Requirements . >5 years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise . Good expertise in related field. Good knowledge about the Drug Development process . Basic project management, good organization and planning skills . Knowledge of relevant regulations (e.g., GMP, HSE etc.) and Novartis specific standards. . Demonstrates problem-solving and idea generation skills . Good presentation skills Fundamental Leadership skills. . Very good communication, negotiation, and interpersonal skills. Ability to work in interdisciplinary teams. Why Novartis 766 million lives were touched by Novartis medicines in 2021, and while we\'re proud of this, we know there is so much more we could do to help improve and extend people\'s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! 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:

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Job Detail

  • Job Id
    JD3098023
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    India, India
  • Education
    Not mentioned
  • Experience
    Year