Purpose of Job The Clinical Data Analysis I's role is responsible for site contract, budget and payment data maintenance, including the financial data entry and reconciliation activities to support the delivery of clinical financial data according to quality and integrity specifications and project timelines. This role reports to the Manager or higher.
Major Responsibilities 61 Supports and works closely with contract associates / contract managers for assigned clinical studies or clinical sites.
61 Performs data entry/reconciliation activities in term of the clinical financial data, including budget, contract and the payment data.
61 Maintenance the data quality in clinical trial financial systems.
61 Generates and delivers reports to study team members.
61 Supports CTA and Project in the data validation across different sources.
61 Helps to ensure CBO documents are filed per company Standard Operating Procedures (SOP) and Work Instructions (WI).
61 May work closely with technical database builders during multiple database integration.
61 Participates in User Acceptance Testing (UAT) activities for clinical financial database build and modifications.
61 Participates in UAT activities for data transfers and programmed report outputs.
61 Assists with Site and User management in clinical financial database of assigned clinical studies.
61 May work with other members of Clinical Study Team (CST) in support of timelines and data-related deliverables.
61 May help identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members.
61 Support CBO data analysis, if required.
61 Other duties as assigned.
Qualification 61 Bachelor’s degree or equivalent in a health-related field
61 More than 1 year of experience in clinical trial investigator contract, or Investigator Payment, or clinical operations, or clinical data management in the biotech/pharmaceutical/CRO industry or the relevant clinical research field
61 Ability to work in a team environment and collaborate with peers
61 Understanding for ICH and regulatory environment as it pertains to data management
61 Good interpersonal skills
61 Good written, verbal and organizational skills
61 Good English written skills.
61 Must be detail-oriented