STATEMENT OF WORK
Position: EOCRU Clinical Trial Data Manager
Status: Full time hiring
Starting: Approx. July 2017
Institutions Summary:
The Eijkman-Oxford Clinical Research Unit (EOCRU) opened in 2008 with the signing of a memorandum of understanding between the Eijkman Institute for Molecular Biology and the University of Oxford, expressing the will to conduct collaborative research on infectious diseases impacting the health of Indonesians and residents of other Southeast Asian nations. In conducting the work especially in Indonesia, EOCRU is assisted by Alliance for Emerging and Re-emerging Disease Threats in Asia Foundation (ALERTAsia), a local foundation assists in research grant management and capacity building for local researchers.
Position Summary:
Overall, a Clinical Trial Data Manager (CTDM) is responsible for collecting data from a variety of clinical research projects conducted under EOCRU and its collaboration with both local and international partners. S/he will work collaboratively to ensure data is collected and managed properly, and reported accurately by training, supervising and monitoring data entry teams at several separate sites in Jakarta and elsewhere. Preparing reports, developing data charts and other presentation materials are classified as important pieces of the collaborative process between the clinical data manager and the research team. Because the work is collaborative in nature, regular group meetings and some travel may be required.
Essential Duties and Responsibilities:
- Provide management support to research team and/or study project, clinical data management team and biostatistics team.
- Participate in the review of clinical research documents, such as protocols, case report forms (CRFs), and report in order to ensure proper data management practices.
- Develop and maintain data management plan (DMP) throughout lifecycle of study project and ensures DMP is followed according to study design and requirements by direct supervising and monitoring the data management teams.
- Participate in development of case report forms (CRFs) in electronic and/or paper based
- Develop database (DB) clinical trial data specifications, including e-CRF design, user requirements, edit rules/checks, query logic and data validations.
- Lead electronic data capture (EDC) database (DB) specification process by direct supervising the data management teams.
- Develop data transfer agreement (DTA) to transfer human subject data from one institution to another for research and academic purposes only.
- Reconcile electronic data transfers from study site to sponsor and authorities.
- Develop test scripts and execution logs for User Acceptance Testing (UAT). Coordinate the UAT of e-CRF development and validation documents, included but not limited to: edit and check document, issue logs, and provide UAT summary report.
- Maintain and track the EDC user management and other clinical databases across allocated clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.
- Perform training on study trial for EDC and create user guides.
- Ensure clinical data within EDC is in a good quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
- Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
- Coordinate the archiving of study databases and related documents.
- Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management databases.
- Assist and provide input into study and project level data analysis plan.
- Addressing clinical/research team requests, project plans, and/or e-CRF development activities.
- Participate in the preparation and presentation of research data, when applicable.
- Ensure data system compliance by following the established guidelines of international regulatory authorities.
- Participate in conference calls and/or meetings with vendors.
- Bachelor or Master’s degree in data management systems or related degree and relevant experience.
- Computer literacy and proficiency is a must.
- Ability to manage complex data sets resulting from multiple research projects.
- At least 3 - 5 years data management and/or related work experience with supervisory responsibilities.
- Proficient English speaking and writing abilities.
- Demonstrated ability to work independently.
Location: Jakarta
Duration: 1 year with possible annual extensions.
Note: we will only short list candidates who meet our application requirement.
