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
Assist 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.3. Feasibility Exercises
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.4. Case report form design
Assist the DM Team with CRF design as and when necessary.5. Study database creation
Work closely with the data manager to ensure that study databased are completed in time for SIV.6. Data Discrepancy Management
Ensure data entered is clean and free from discrepanies.7. Other duties
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.Key Requirements :
Bachelor's Degree in Life Sciences, Biomedical Science, or a related fieldAt least 2 years of prior working experience in similar job scopeExcellent written and verbal communication skillsGood organizational and interpersonal skillsProficient in Microsoft Office & PowerpointSelf-motivated and a team playerAbility to complete tasks independently with minimal supervisionAbility to work on multiple projects involving multiple stakeholders concurrentlyPossess an understanding of medical and clinical research terminologyCancer research background will have added advantage