PT Ganesha Aggies Jaya (PTG) is an Indonesian consulting company, specializing in HR and Management. .
Provides a range of data management activities for the Indonesian Research Partnership on Infectious Diseases (INA-RESPOND) in Jakarta, Indonesia (managed by the National Institute of Health Research and Development, Ministry of Health, Indonesia).
Primarally, the position involves setting up, modifying and programming Clinical Research databases, reports and listings. However, the position also involves providing ongoing support and backup to the Lead Data Manager. The candidate must be comfortable working in a fast-paced environment and must be fluent in Bahasa Indonesia and English.
Duties and Responsibilities:
Key duties and responsibilities may include, but are not limited to, the following:
• Provides ongoing support and backup for the Lead Data Manager.
• Provides performance reports to the INA-RESPOND Chairman on an ongoing basis.
• Setup, modify and program Clinical Research databases, such as OpenClinica and other software.
• Responsible for Case Report Form (CRF), electronic and/or paper,design, development, and maintenance.
• Provides technical input on data management for protocol, manual of procedures, and other Data Management-related documents.
• Assists with development of Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
• Writes programs for database edit checks, Data Management reports, data listings, and other requirements.
• Prepares invoicing reports, based on study objective specifications.
• Assists in reconciling AE/SAE data in Safety database and/or other Data Management database.
• Coordinates Quality Control (QC) / Quality Assurance (QA) tesing, including data entry screen testing, database testing and edit check testing.
• Prepares, and provides Clinical Data Management training for research sites and INA-RESPOND staff.
• Develops, generates and manages data queries, reports, and other data related activities.
• Communicates with site(s) regarding the data query or other data management issues.
• Anticipates and identifies potential problems and propose preventive measures and solutions.
• Serves as a representative of the project and Secretariat, communicating professionally and effectively with the clients and all collaborators.
• Because the work is collaborative in nature, regular group meetings and some travel may be required.
• Assists with coordinating the archiving of study databases and related documents.
Required Qualifications, Skills and Experience
• A bachelor’s degree or equivalent tertiary qualification from an accredited institution.
• A minimum of 5 years experience working in a Clinical Research Data Management environment.
• Programmer skills and experience is required.
• OpenClinica, Datafax, R-programming, Java, Oracle post gres and SAS programming skills are advantageous.
• Demonstrates a very high level of technical skill and expertise as pertains to clinical research and development.
• Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Demonstrates high proficiency in project planning and organization and proactively anticipate and identify complex issues and problems.
• Demonstrates good interpersonal skills and communication abilities.
• Demonstrates good decision-making abilities .
• Experience providing training and developing training materials.
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