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:
1.   
Provide
management support to research team and/or study project, clinical data management
team and biostatistics team.
2.   
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.
3.   
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.
4.   
Participate
in development of case report forms (CRFs) in electronic and/or paper based.
5.   
Develop
database (DB) clinical trial data specifications, including e-CRF design, user
requirements, edit rules/checks, query logic and data validations.
6.   
Lead
electronic data capture (EDC) database (DB) specification process by direct
supervising the data management teams.
7.  Develop
data transfer agreement (DTA) to transfer human subject data from one
institution to another for research and academic purposes only. 
8.   
Reconcile
electronic data transfers from study site to sponsor and authorities.
9.   

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.
10. 
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.
11. 
Perform
training on study trial for EDC and create user guides.
12. 
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.
13. 
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.
14. 
Coordinate
the archiving of study databases and related documents.
15. 

Perform
close-out audit, as specified, for closing of study trial in EDC or other
clinical data management databases.
16. 
Assist
and provide input into study and project level data analysis plan.
17. 
Addressing
clinical/research team requests, project plans, and/or e-CRF development activities.

18. 
Participate
in the preparation and presentation of research data, when applicable.
19. 
Ensure
data system compliance by following the established guidelines of international
regulatory authorities.
20. 
Participate
in conference calls and/or meetings with vendors.
 
Qualifications:      1.   
Bachelor
or Master’s degree in data management systems or related degree and relevant
experience.
2.   
Computer
literacy and proficiency is a must.
3.   
Ability
to manage complex data sets resulting from multiple research projects.
4.   
At
least 3 – 5 years data management and/or related work experience with supervisory
responsibilities.
5.   
Proficient
English speaking and writing abilities.
6.   
Demonstrated

ability to work independently.
 Application requirement (Cover Letter, CV, three name and address of professional referees, and salary history) should be sent via e-mail to: hro@alertasia.org.  Please quote the reference “Clinical Trial Data Manager”. Shortlisting candidates will start onMonday, 1 May 2017.Location: JakartaDuration: 1 year with possible annual extensions.Note: we will only short list candidates who meet our application requirement.