
Clinical Trial Business Process Specialist
3 days ago
We are seeking a seasoned Business Analyst to join our team.
The ideal candidate will have hands-on experience with clinical trial systems and have played a key role in 2–3 end-to-end technology implementations across the clinical trials value chain.
This role demands a deep understanding of business processes, stakeholder collaboration, and Agile delivery practices.
- Lead and facilitate requirements gathering sessions with stakeholders across Clinical Operations and IT teams.
- Author and maintain User Requirement Specifications (URS) and ensure alignment with business and regulatory needs.
- Support User Acceptance Testing (UAT) by preparing test scripts, coordinating execution, and capturing feedback.
- Manage Jira boards for tracking user stories, tasks, bugs, and deployment workflows.
- Act as a domain consultant and business analyst across 2–3 full-cycle technology implementations within the clinical trials value chain.
- Collaborate with cross-functional teams including developers, testers, product owners, and business users in an Agile environment.
Required skills and qualifications include:
- ~5–8 years of experience as a Business Analyst in the Life Sciences / Pharmaceutical industry.
- ~ Strong domain knowledge in Clinical Trials and Clinical Operations processes.
- ~ Proven experience in Agile software development and delivery.
- ~ Hands-on experience with clinical trial systems and tools mentioned above.
- ~ Excellent communication, documentation, and stakeholder engagement skills.
- ~ Experience in managing end-to-end software development lifecycle from requirements to deployment.
Preferred qualifications include:
- Experience working with global pharmaceutical clients and CROs.
- Familiarity with Gx P compliance and validation processes.
- Certifications in Business Analysis (CBAP, PMI-PBA) or Agile (CSM, SAFe).
- Exposure to enterprise portfolio management tools like Planisware.
The successful candidate will have acted as a Business Analyst and Domain Consultant on at least 2–3 end-to-end technology implementations within the clinical trials value chain, covering areas such as planning, execution, monitoring, and reporting.
Should be able to translate complex clinical operations requirements into actionable technical specifications.
Must be comfortable working in a global delivery model and managing stakeholders across geographies.
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