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Specialized clinical research requirement reduces applicant pool despite known CRO brand and mid-level seniority.
Requires clinical research and regulatory experience, limiting cross-industry transferability.
Explicit 5–7 years with 3 years clinical research plus mandatory clinical systems and regulatory expertise.
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Lead comprehensive analysis and improvements of clinical research business processes and workflows to optimize efficiency, quality, and compliance.
Gather, translate, and validate complex stakeholder requirements; design and document solutions to support clinical operations and system implementations (e.g., EDC, CTMS).
Drive process standardization, automation initiatives, and participate in medium to large-scale project management, including mentoring junior analysts.
5 to 7 years of business analysis experience including at least 3 years in clinical research or pharmaceutical industry.
Strong knowledge of clinical trial processes, clinical systems implementation (EDC, CTMS, eTMF), and regulatory requirements (GCP, ICH, FDA, EMA).
Proficiency with business analysis tools such as JIRA, Confluence, Visio and familiarity with process modeling (BPMN, UML).
Bachelor's degree in business administration, information systems, life sciences, or related field.
Experienced in leading requirements gathering, process improvement, and solution design in regulated clinical research environments.
Practiced in using both Agile and traditional software development methodologies for clinical systems.
Strong leadership skills demonstrated by mentoring and coordinating cross-functional teams in medium to large projects.