Confidential ยท 2 days ago
CTMS Business Analyst
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Responsibilities
Requirement Gathering and Analysis: Work with stakeholders to gather, analyze, and document requirements for the CTMS.
System Design and Configuration: Assist in the design and configuration of the CTMS to meet organizational needs.
Process Improvement: Evaluate and recommend improvements to current clinical trial processes.
Training and Support: Provide training and ongoing support to CTMS users. Develop user manuals and conduct training sessions.
Data Analysis and Reporting: Generate and analyze reports from the CTMS to support decision-making and ensure compliance.
Compliance and Quality Assurance: Ensure the CTMS complies with regulatory requirements and industry standards through regular audits and quality checks.
Project Management: Manage CTMS-related projects, coordinating with IT teams, external vendors, and internal stakeholders.
Qualification
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Required
Bachelor's degree in Life Sciences, Information Technology, Business Administration, or a related field
Minimum of 3-5 years of experience as a Business Analyst, preferably within a clinical trial or pharmaceutical environment
Proficiency with CTMS software, databases, and basic programming or scripting
Certified at JLPT N3, N2, or N1 level in Japanese Language
Strong analytical and problem-solving skills
Excellent verbal and written communication skills in both English and Japanese
Experience managing projects and ensuring timely completion within budget
Preferred
Experience with specific CTMS platforms such as Medidata, Oracle Siebel, Veeva Systems, Bioclinica, or MasterControl
Understanding of regulatory requirements and industry standards for clinical trials