DATA MANAGER (please click to apply online)
Job Description
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).
Primarily, 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 the development of the Data Management Plan (DMP), maintains DMP throughout the lifecycle of the 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 the Safety database and/or other Data Management database.
- Coordinates Quality Control (QC) / Quality Assurance (QA) testing, 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 the 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 of 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.
Clinical Research Associate (please click to apply online)
Job Description
Responsible for performing and coordinating all monitoring strategies for clinical research studies for the Indonesia Research Partnership on Infectious Diseases (INA-RESPOND) in Jakarta, Indonesia (managed by the National Institute of Health Research and Development, Ministry of Health, Indonesia). Conducts site qualification (SVQ), site initiation (SIV), site monitoring (SMV), and site close-out visits (SCV) to determine the protocol and regulatory compliance. Assures compliance with GCP, ICH, and SOPs set forth by NIAID. Exercises delegated training and supervisory responsibility for CRAs assigned to a specific project.
Duties and Responsibilities:
- Monitors activities at clinical study sites by conducting SQVs, SIVs, SVM’s, and SCVs
- Oversees and participates in identifying and recruiting physicians and study sites, verifying qualifications and capabilities to successfully manage and conduct clinical research.
- Maintains a professional working relationship with all clients, investigators, and clinical study sites.
- Reviews and approves all essential documents required for implementing, monitoring, and evaluating clinical research at assigned sites, per established guidelines.
- Monitors the progress of clinical trials by verifying the accurate and complete collection/ recording of data on case report forms or databases, without supervision.
- Reviews AE/SAE reporting for compliance with the protocol, national and local regulations, and established guidelines.
- Completion of comprehensive monitoring reports and related correspondence in a timely manner following each monitoring visit, with no errors/edits needed.
- Reviews and investigator study files to ensure compliance with all applicable regulatory and client requirements.
- Provides mentoring for CRA trainees in the field. Able to demonstrate the CRA’s role in preparing, monitoring, and reporting results of clinical trials.
- Keeps abreast of ICH/GCP guidelines, SOPs related to clinical monitoring, and current clinical developments in assigned therapeutic areas, independently.
- Provides project management assistance as delegated, including monitoring report review, assisting in the design of protocol-specific manuals and documents and team training
- Assists with the development and review of clinical research site SOPs.
- Assists in the development of clinical research site staff trainings.
- Perform other duties as assigned.
- Ability to travel an annual average of 50% – 75%.
Qualifications:
Education and/or Experience:
- BS/BA in a life sciences program or field; nursing degree preferred, but not required
- Minimum two years as a clinical monitor, with documented experience in performing SVQ/SIV/SMV/SCVs independently without supervision
Knowledge/Skills/Other Requirements
- Written and verbal fluency in English and Bahasa Indonesia
- Strong initiative and ability to work without supervision
- Strong organizational skills with keen attention to detail
- Excellent communication skills (written and verbal) with the ability to communicate effectively with clinical site staff
- Team player with a strong customer focus and excellent interpersonal skills
- Able to effectively manage multiple priorities within assigned tasks
- Comprehensive understanding of ICH/GCP guidelines, United States and Indonesian clinical research regulations, medical terminology and clinical research processes
- Demonstrated ability to mentor and train other monitors in a positive and effective manner
understands the relevance, importance, and inter-relationship of other departments to the success of the clinical research including data management, biostatistics, and regulatory- quality assurance - Excellent computer skills and ability to learn and become proficient with appropriate software; working knowledge of Word, Excel, and PowerPoint.
- Ability to utilize problem-solving techniques applicable to constantly changing environment
- Prior experience in a Contract Research Organization (CRO) is preferred
- Prior experience working for a United States government-funded research program is preferred
How to Apply
- Please review the following list for the available positions.
- Click on the position title to proceed to our online form.
- Choose the desired position from the drop-down menu and proceed to the available form. Please type, do not cut and paste
- Submit your resume and or a CV in PDF format.
- Submit your current picture in the format of .jpg, .gif, .png, or .bmp with the size no more than 200kb.
- Submit your cover letter addressing each selection criterion detailed in the position description with specific and comprehensive information supporting each item. (PDF format)
- Ensure you have addressed all the questions in the provided form.
- Click on SUBMIT to finalize the submission.
- Each applicant can apply for more than one position.
Should you require further assistance or if you have any questions, contact us at work.with@ptghrsys.com and our staff will respond to your inquiry based on the order in which it was received.
