Cdm Process Standards Manager Job In The Medicines Company In India, Ireland

Job DescriptionJob Description 100,000 and more!That's how many patients are treated in our studies And every year, 3 million documents are uploaded in the electronic Trial Master Files to preserve the story of the study and ensure innovative medicines can reach even more patients worldwideBut in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of dataAccountable for developing and implementing processes & standards and TMF (Trial Master File) Reference Model governance related to the delivery of CDGM services and the adoption of TMF and good documentation practices across the businessDrives implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis.

The role can be based in either in Ireland, United Kingdom or IndiaMajor Accountabilities: Accountable for developing and implementing processes & standards related to the delivery of CDGM services and the adoption of TMF and good documentation practices across the business Drives implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at Novartis.

Develop and maintain content related to TMF and document management standard operating procedures, working practices, guidelines, templates and other policy written standards to support inspection readiness in alignment with ALCOA CCEA principles and good documentation practices, partnering with key stakeholders across the business Support the TMF Reference Model governance board providing fact-based subject matter expertise on essential documents lists, taxonomy and metadata management in close partnership with CDM Technology and line function communities owning the content.

Support the development and delivery of strategies to increase the adoption and improvement in TMF health and document management across stakeholder groups, providing clear and quality content for the creation of TMF/document management learning curricula Facilitate discussions with CDGM LT and others relating to trends and issues in processes and standards Partner with service providers and internal stakeholders to develop fit for purpose written standards for 3rd party partners and embed their use as part of robust oversight of third-party service performance.

Serves as Subject Matter Expert on TMF formal and informal processes and TMF Reference Model management in collaboration with key stakeholders Provide support in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs in relation to TMF Processes and Reference Model Act as CDGM point of contact for other projects and initiatives, to ensure engagement and involvement of CDGM as neededDiversity & Inclusion / EEO Minimum Requirements What you'll bring to the role:.

Bachelor's degree or equivalent and relevant industry experience English fluency (written, oral) required Minimum of 5 years working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organisations) with specific experience in clinical documentation and/or records & information management Demonstrated success in planning and executing cross functional projects.

Strong influencing and presentation skills Ability to communicate effectively at all levels High organisational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.

Good negotiation, problem solving and conflict resolution skills experience establishing trusted relationships with internal and external stakeholders#GCO#CDGMYou'll receive:Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunitiesWhy consider Novartis769 million That's how many lives our products touched in 2020.

And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's livesWe believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment Where you're given opportunities to explore the power of digital and data Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challengesImagine what you could do 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 learn more about Novartis and our career opportunities, join the Novartis Network here: Novartis Ireland Ltd has been certified as a Top Employer 2022 by the Top Employers Institute for its exceptional employee offerings!

The Medicines Company is looking for .

The Medicines Company is looking for Any Graduate / Post Graduate profile candidates.