Clinical Data Manager

1 week ago

Singapore PRESTIGE BIOPHARMA LIMITED Full time

**General Description**

The Clinical Data Manager will be responsible for leading and/or supporting multiple clinical studies and programs it from the Data Management perspective.

The role may also be responsible for process development and process improvement activities to ensure quality, compliance, consistency, as well as increase operational efficiency within Data Management.

**Responsibility**
- Develop trial database, including eCRF design, user requirements, edit rules/checks, query logic and data validations (with mínimal guidance).
- Perform comprehensive data management tasks including data review, writing, and resolving data clarifications requests.
- Develop and manage DM documents like Data Handling Plan (DHP), Data Review Plan (DRP), Data Management Plan for assigned trials, Manual Listings plan and validation.
- Review trial Protocols and develop Case Report Forms.
- Ability to perform EDC testing including test case creation, UAT.
- Work closely with the internal/external cross-functional team (CRAs, Project Managers, Medical monitors, Statisticians etc) to ensure all the data related issues are resolved.
- Review documentation and requirements for new projects and anticipate impact to Data Management (DM) standards/processes.
- Manage eSource/EDC users and other Clinical databases, including but not limited to, compiling master user lists and activating/deactivating user accounts.
- Perform user training for both internal and external users.
- Create user guides and SOPs.
- Assist in reconciling AE/SAE data in Data Management database.
- Manage multiple projects, ensuring that timelines are met, and deliverables are of utmost quality.

**Qualifications**
- Bachelor’s degree or educational equivalent in clinical, biological sciences, nursing or related field.
- At least four (4) years of core Clinical Data Management in the pharmaceutical or CRO industry.

**Additional Skills**
- Ability to successfully manage multiple tasks and timelines with mínimal supervision
- Knowledge of ICH-GCP, 21CFR Part 11
- Good understanding and sound knowledge in Clinical research, Clinical trial processes, related regulatory requirements and terminologies.
- Applicable knowledge in working with other clinical databases
- Medidata Rave, Veeva, Viedoc and/or Oracle preferred.
- Excellent verbal and written skills, good organizational, interpersonal, and team skills.
- Experience in working on Phase I- III clinical trials

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