Associate Clinical Data Facilitator

Novo Nordisk India Pvt Ltd; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Novo Global Business Services (GBS) in Bangalore, India is seeking an Associate Clinical Data Facilitator. You will ensure the clinical trial data is accurate, compliant and ready for regulatory submission.

You will automate repetitive tasks using Python, VBA and Power BI, and prepare CDISC submission documents while maintaining EDMS archives. With 2–3 years in pharma, you’ll collaborate across teams in a Global Business Services setting, supporting data management, regulatory submissions and

Qualifications

• Master’s or Bachelor’s degree in Life Science, Computer Science, Information Technology, Clinical Information Management or equivalent.
• 2–3 years of pharmaceutical industry experience.
• Strong knowledge of Python, VBA/macros, Power BI and related automation tools.
• Familiarity with GxP guidelines, CDISC and eCTD requirements.

Responsibilities

• Own the quality and submission-readiness of clinical data forms for assigned trials.
• Compile, bookmark, merge and hyperlink sample and completed eCRFs and appendices for reports; archive in EDMS on time.
• Prepare (e)CRFs and CDISC submission documents to meet eCTD standards; run electronic quality control checks.
• Support the decommissioning of EDC and eCOA systems, including archival and retrieval of audit trails and reports.
• Manage scanning, tracking and archival of paper-based clinical documents in line with records management.
• Identify repetitive manual activities and build sustainable improvements using Python, VBA/macros and Power BI.
• Take ownership of trials; spot risks to quality or timelines and align on deliverables with stakeholders.

Skills

Python

VBA/macros

Power BI

English fluency

Collaboration

Process automation

Education

Master’s or Bachelor’s in Life Science/CS/IT/Clinical Information Management

Tools

EDMS

CDISC/eCTD tooling

Job description

Associate Clinical Data Facilitator

Company: Novo Global Business Services (GBS)
Department: Research & Development
Location: Bangalore, India

Your impact begins here. 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.

What you can expect here

You will work in a collaborative, international setting where your expertise is valued and your ideas for doing things better are welcome. You will build new skills by working with colleagues across the clinical data value chain, and by developing your automation and AI tool capabilities on real work that the team uses every day. You will be supported to perform at your best and trusted to take ownership of your trials. Clear expectations and a culture that rewards results mean you can see the effect of your work. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Experience Level Mid Level