Job Title: Senior Business Analyst (Clinical Operations)
Location: NJ / Remote
Type: Contract (C2C)
Experience Required
- 10+ years as Business Analyst
- 5+ years in Clinical/Pharma domain
Job Summary
Senior Business Analyst with strong expertise in Clinical Operations (ClinOps) and Clinical Trial Management Systems (CTMS) to support clinical trial lifecycle initiatives. The role focuses on bridging business and technology, driving process improvements, and ensuring solutions align with real-world clinical execution.
Required Skills
- Strong experience in Clinical Operations (ClinOps)
- Hands-on experience with CTMS
- Expertise in study start-up & site activation
- Strong BA skills (requirements, UAT, process mapping)
- Experience with Agile methodology
- Knowledge of clinical workflows & regulatory processes
Key Responsibilities
- Conduct user research with clinical stakeholders (CRAs, Study Managers, Site Activation Leads)
- Create as-is / to-be process maps for clinical trial lifecycle (feasibility, site activation, enrollment)
- Develop BRDs, functional specs, user stories, and acceptance criteria
- Lead UAT activities (test scripts, defect triage, sign-off)
- Work on CTMS systems for trial tracking and site-level workflows
- Support study start-up processes (site qualification, IRB/EC submissions, activation timelines)
- Perform gap analysis between current processes and target platforms
- Drive change management & user adoption (training, documentation)
- Participate in Agile ceremonies (sprint planning, backlog grooming)
Ensure compliance with Good Clinical Practice (GCP)
Email is best way to reach me.
Looking forward to working with you
Thanks & Regards,
Harshith Reddy
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