We are seeking a Business Analyst (BA) with experience in clinical trials software (eCOA/EDC) to join our India team. The BA will play a pivotal role in requirement gathering, sprint planning, and collaboration with project managers and scrum teams, while working across time zones with teams in India, the UK, and the US.
Responsibilities:
Partner with Product Managers, Scrum Masters, and clinicians to gather, validate, and document requirements.
Translate business and clinical trial needs into functional specifications, user stories, and acceptance criteria.
Participate actively in sprint planning, backlog refinement, and cross-team ceremonies.
Ensure compliance with 21 CFR Part 11 and related regulatory standards.
Collaborate with engineering, DevOps, and QA teams to deliver high-quality clinical trial technology solutions.
Act as the liaison between stakeholders and development teams across India and the UK.
Support the scaling of eCOA and EDC solutions from trial design through execution and reporting.
Experience:
5 years experience as a Business Analyst, preferably in the life sciences, pharma, or clinical trials domain.
Strong background in requirement elicitation, documentation, and stakeholder management.
Experience working in Agile environments with distributed teams.
Prior experience in software for clinical trials (EDC or eCOA platforms) is highly preferred.
Knowledge of 21 CFR Part 11 regulated environments is required.
Strong interpersonal and communication skills, with flexibility to work extended hours overlapping US/UK time zones.
