Description :
1. Requirement Analysis & Documentation :
- Work independently with product managers and engineering leads to understand, validate, and translate business needs into functional specifications.
- Create clear and comprehensive user stories, acceptance criteria, workflows, and use cases.
- Assist Scrum Masters with story sizing, backlog refinement, and sprint planning.
- Ensure all documentation meets quality standards and aligns with business and technical expectations.
2. Collaboration & Stakeholder Management :
Collaborate extensively with cross-functional teams including product, engineering, QA, and design.Participate actively in daily stand-ups, sprint ceremonies, and project discussions.Communicate progress, risks, and challenges proactively to stakeholders.3. Functional Expertise & Domain Contribution :
Utilize strong clinical trials domain expertise, particularly in EDC and eCOA systems, to guide product development decisions.Provide insights on regulatory requirements, data capture standards, and user experience considerations specific to clinical trial workflows.Validate product features from a user and business perspective.4. Ownership & Delivery :
Work independently on assigned tasks with minimal supervision.Ensure timely delivery of high-quality requirements and documentation.Take initiative to seek clarity, resolve blockers, and align deliverables with sprint commitments.5. Mentorship & Team Development :
Mentor, guide, and support junior analysts when required.Help in training team members on domain knowledge, processes, and documentation standards.Participate in performance evaluations of subordinates if assigned.6. Continuous Improvement :
Identify opportunities for process improvements in requirement gathering, sprint planning, documentation, and stakeholder communication.Develop additional skills and encourage team members to upskill as per project needs.Mandatory Skills :
Strong experience in clinical trials, specifically with Electronic Data Capture (EDC) or Electronic Clinical Outcome Assessment (eCOA) systems.Proven ability to translate business requirements into well-defined user stories and functional documentation.Experience working in Agile / Scrum environments.Excellent communication, analytical thinking, and problem-solving skills.Preferred Skills :
Experience with global stakeholders in a product development setup.Exposure to regulatory requirements (GxP, CFR Part 11, etc.) related to clinical trial systems.Understanding of basic technical concepts like APIs, workflows, data models, and integrations.Ability to manage multiple priorities and deliver under tight timelines.Personal Attributes :
Strong ownership mindset with the ability to work independently.Proactive, organized, and self-motivated.Collaborative spirit and willingness to contribute to a high-performance culture.Detail-oriented with a commitment to quality.(ref : hirist.tech)