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 ? Supports and works closely with contract associates / contract managers for assigned clinical studies or clinical sites.
? Performs data entry/reconciliation activities in term of the clinical financial data, including budget, contract and the payment data.
? Maintenance the data quality in clinical trial financial systems.
? Generates and delivers reports to study team members.
? Supports CTA and Project in the data validation across different sources.
? Helps to ensure CBO documents are filed per company Standard Operating Procedures (SOP) and Work Instructions (WI).
? May work closely with technical database builders during multiple database integration.
? Participates in User Acceptance Testing (UAT) activities for clinical financial database build and modifications.
? Participates in UAT activities for data transfers and programmed report outputs.
? Assists with Site and User management in clinical financial database of assigned clinical studies.
? May work with other members of Clinical Study Team (CST) in support of timelines and data-related deliverables.
? 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.
? Support CBO data analysis, if required.
? Other duties as assigned.
Qualification ? Bachelor’s degree or equivalent in a health-related field
? 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
? Ability to work in a team environment and collaborate with peers
? Understanding for ICH and regulatory environment as it pertains to data management
? Good interpersonal skills
? Good written, verbal and organizational skills
? Good English written skills.
? Must be detail-oriented
At ICON we believe that our people are the most important asset. It is they who have helped to make ICON the success it is. Their commitment to clients, quality and delivery has earned ICON its enviable reputation. About DOCS: DOCS- ICON Resourcing Solutions is a division of ICON plc that provides global staffing solutions to Pharmaceutical, Biotechnology, Medical Device companies and CROs in over 39 countries. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. ICON has been in APAC since 1996 and the DOCS division of ICON is now expanding in the APAC region. Our Services: We are a specialist recruitment division focusing in Clinical Research, Medical Affairs, Regulatory Affairs, Drug Safety, Health Economics, Data Management& Statistics, Quality Assurance etc. Our full-spectrum resourcing solutions extend from contingent staffing, to functional resourcing, large-scale FSP and executive search. In addition, DOCS has developed a tailored training division‘CRAcademy’ to provide Traineeships and Training. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. Our History: DOCS was formed in The Netherlands in 1997 and grew to become the premier resourcing provider to the European pharmaceutical industry. The company was acquired by ICON plc in 2007 and was merged with ICON’s existing resourcing division, ICON Contracting Solutions. The merged company is now known as DOCS, and offers clients over 15 years of experience in the provision of global resourcing solutions. For more information, please visit www.docsglobal.com& www.iconplc.com.