Clinical Data Analyst

Harvest Integrated Research Organization (HiRO) is a globally-oriented, innovative boutique CRO dedicated to elevating cross-border clinical trial pathways. As an emerging global CRO, HiRO collaborates closely with biotech and pharmaceutical companies, aiming to efficiently bridge the gap between laboratory research and market commercialization. Our team members are curious and determined, always looking to transform challenges into opportunities. Our mission is to provide cutting-edge and capital-efficient solutions, ultimately benefiting patients worldwide.

We are seeking a Data Management Lead based in Japan to join our dynamic team.

Key Responsibilities

• Serve as Clinical Data Analyst for one or more clinical trials assuming responsibility for DM activities including selection and application of data acquisition standards, database design, development and maintenance of the Data Management Plan, data review and query management, data access, Data Management metrics reporting, database release, and submission related activities.
• Provide early input into protocol design and contracting process focused on data management issues.
• Proactively communicate with project team to share project status, risk assessment, and outstanding item resolution status. Ensure compliance with standard key performance indicators according to process.
• Lead the development of eCRFs, database and all other DM activities for the study handled internally by interacting with other functional area representatives.
• Ensure the TMF maintenance of Data Management is on time with good quality.

Qualifications

• Bachelor's Degree in Clinical, Biological or Mathematical Sciences or related field, or nursing qualification required.
• 1 year of relevant work experience. Equivalent combination of education, training, and experience is acceptable.
• Advanced knowledge of Data Management processes and systems.
• Proven staff management skills, strong leadership, motivational and influencing skills.
• Ability to work on multiple projects and manage competing priorities effectively.
• Effective mentoring and developed coaching skills.