Associate Clinical Data Facilitator

As Associate Clinical Data Facilitator in Global Business Services in Bangalore, you will make sure the clinical trial data behind Novo's treatments is accurate, compliant and ready for submission. You will prepare the forms and documents regulatory authorities review, and use Python, VBA and Power BI to replace repetitive manual work with smarter, faster ways of working. Your work helps new treatments move through clinical development with speed and confidence, for people living with serious chronic diseases.

What you'll bring:

• A Master's or Bachelor's degree in Life Science, Computer Science, Information Technology, Clinical Information Management or an equivalent qualification.
• A minimum of 2-3 years of experience in the pharmaceutical industry.
• Strong working knowledge of Python, VBA/macros, Power BI and related automation tools, with hands-on experience in process simplification and troubleshooting.
• Familiarity with GxP guidelines, drug development processes and clinical data standards, including CDISC and eCTD requirements.
• Excellent communication, presentation and coordination skills, with fluent written and spoken English.
• The ability to collaborate effectively across professional, regional and cultural boundaries.

Preferrably, at least 2 years of experience within clinical data management systems, project management or related areas:

What you'll do:

• You will own the quality and submission-readiness of clinical data forms for your assigned trials, while making the way the team works simpler and more automated.
• Compile, bookmark, merge and hyperlink sample and completed (e)CRFs, and appendices for Clinical Trial Reports and Non-interventional Study Reports, and make sure they are archived in EDMS on time.
• Prepare (e)CRFs and CDISC submission documents (aCRF, cSDRG) to meet eCTD compliance standards, run electronic quality control checks and support submission deliverables at project level.
• Support the decommissioning of EDC and eCOA systems, including retrieval and archival of audit trails, access reports, Services Documentation Packages and Sponsor archive packages.
• Manage the scanning, tracking and archival of paper-based clinical documents, such as CRFs and patient diaries, in line with records management requirements.
• Identify repetitive manual activities and build sustainable improvements using Python, VBA/macros, Power BI and other AI tools.
• Take ownership of your assigned trials: spot risks to quality or timelines early, propose corrective actions and align on deliverables with stakeholders.

Who you'll work with:

You will join the Clinical Data Facilitator team within Clinical Data Management & Programming, part of Global Business Services in Bangalore. The team manages clinical data forms from end to end across Novo's global trial portfolio, working where clinical data management, regulatory submissions and process innovation meet. In Research & Development, colleagues explore scientific ideas and advance them towards clinical testing. Curiosity, data, technology, collaboration and operational excellence come together to help meet future health needs. Day to day, you will partner with Clinical Data Managers, SDTM Programmers, Clinical Operations and Regulatory Affairs, as well as vendors and CROs. Together you will agree on deliverables and timelines, speak up early when something is at risk, and keep trials moving with clarity.