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Data Management Coordinator (Clinical Trials Office)
NATIONAL CANCER CENTRE OF SINGAPORE PTE LTDSingapore30+ days ago
Job descriptionAssist CRCs in reporting SAEs and safety updates Eg. SUSARs. Reporting of safety updates and SAEs must be in accordance with the protocol, sponsor, SGGCP, IRB and HSA requirements. Assist in feasibility exercises conducted by trial sponsors.Ensure NDAs executed before exchanging confidential information. Ensure timely correspondences with sponsors and timely reply on feasibility exercises. Maintain and update feasibility database. File and safe keep feasibility documents. Assist the DM Team with CRF design as and when necessary. Work closely with the data manager to ensure that study databased are completed in time for SIV. Ensure data entered is clean and free from discrepanies. As assigned by the supervisor and may include the following : Assist investigators to register and maintain trials in the clinicaltrials.gov database. Assist CRCs to apply for HSA or IRB application whenever necessary. Bachelor's Degree in Life Sciences, Biomedical Science, or a related field At least 2 years of prior working experience in similar job scope Excellent written and verbal communication skills Good organizational and interpersonal skills Proficient in Microsoft Office & Powerpoint Self-motivated and a team player Ability to complete tasks independently with minimal supervision Ability to work on multiple projects involving multiple stakeholders concurrently Possess an understanding of medical and clinical research terminology Cancer research background will have added advantage
We are looking for a driven Data Management Coordinator (DMC) to join the Clinical Trials Office team!
The DMC will assist in data entry of studies and help resolve data discrepancies, ensuring that study data are recorded in accordance with the protocol, Good Clinical Practice (GCP) Guidelines, all applicable regulatory requirements and the Clinical Trials office' Standard Operating Procedures.
Key Responsibilities :
1. Filling of case report forms for both sponsored trials and IITs
- Enter research patient data into paper case report forms and various electronic data capture systems.
- Assist CRCs in answering data queries.
- Attend Site Initiation Meeting and site audits and inspections.
- Assist CRCs in reporting SAEs and safety updates.
2. Reporting SAEs and safety updates
3. Feasibility Exercises
4. Case report form design
5. Study database creation
6. Data Discrepancy Management
7. Other duties
Key Requirements :
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Clinical Coordinator • Singapore