Offer summary

Qualifications:

Experience in Clinical Trials and SDTM generation., Strong skills in requirements gathering and backlog management., Ability to translate business needs into product requirements., Familiarity with project management principles and tools like Jira..

Key responsibilities:

Clarify business rules, processes, and workflows for development efforts.

Manage the product backlog and prioritize features for delivery.

Collaborate with the team to refine user stories and ensure alignment with business requirements.

Support project managers in planning, risk management, and tracking project progress.

Katalyst Healthcare's & Life Sciences (Katalyst HLS) is a Global Contract Research Organisation that provides End-to-End Clinical Research Services for Healthcare and Life Sciences companies globally. At Katalyst HLS offers ICH-GCP compliant clinical trial services from Phase I–IV in all key therapeutic areas to support clinical development and research requirements and also provides validation, quality and regulatory services for Pharma/Bio-Pharma/Medical Device industries. Services:- Clinical Trial Management- Clinical Data Management- Biostatistics & Statistical Programming- Medical Writing- Pharmacovigilance- Quality and Regulatory Affairs- GMP, GLP and GCP Validations- Manufacturing Process Validations- Equipments & Instruments Validations- Computer Systems Validations- Human Resourcing

Job description

Responsibilities and Requirements:

We have a long-term, 100% remote contract opportunity for a life sciences Clinical Trials Business Analyst with Study Data Tabulation Model (SDTM) experience.
Our client is currently seeking a Clinical Business Analyst to support a project involving SDTM generation.

Clarify business rules, processes, and workflows to aid in development efforts.
Requirements gathering and backlog management.
Understand and translate business needs into well-defined product requirements.
Prioritize and manage the product backlog to ensure the delivery of valuable features.
Collaborate with the team to refine and clarify user stories, ensuring they are well-defined in Jira, testable, and aligned with business requirements.
Provide detailed acceptance criteria and scenarios for user stories.
Facilitate communication between stakeholders and the development team.
Project Management support.
Support project managers by contributing to project planning, risk management, and tracking project progress.