Clinical Specialist 4.2 ★

Mô tả Công việc

JOB SUMMARY

The Data Manager is a member of the Data Management team responsible for the gathering requirement, design, construction, integration, testing, verification and maintenance of required clinical data management system (CDMS) platforms including CliRes (in-house web-based applications for clinical trials), RedCAP and any others.

The Data Manager will provide specialized knowledge and detailed attention to lead and carry out data management and data review activities in support of one or more clinical research studies.

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KEY TASKS & RESPONSIBILITIES

- Responsible for the role which includes executing the design, documentation, testing, and implementation of data applications systems and processes in support of research and operation teams.

- Responsible for maintaining and development of the Centralised CliRes data management system and its extensible Android EDC platform.

- Responsible for studying and applying data management platforms that OUCRU have involved with collaborators in different projects.

- Working within study teams as an extended team member to define project timelines in the execution of clinical data management operations.

- Collaborates with peers within and outside the organization to pro-actively manage data availability and integration.

- Conducts their work activities in compliance with all relevant regulations, ICH, and CFR guidelines as well as all OUCRU policies and SOPS.

- Conduct training of study site personnel in eCRF completion, and data clarification processes.

- Coordination of Data Management Data Review activities and ensuring completion of all activities leading to the Study Database Lock.

- Responsible for the role which includes the execution of the data review strategy for one or more studies as defined by the individual study Data Management Plan.

- Initiate and manages the data clarification process, coordinating with other stakeholders to ensure appropriate resolution to all data clarifications prior to database lock.

- Assist with the clinical data management study documentation (e.g. Data Management Plan, Edit Check Specifications, etc.), and supporting the review in accordance with existing standards.

- Responsible for the representation of the clinical data management & programming organization in one or more clinical studies.

- Responsible for the implementation of quality, efficient, and consistent approaches to carrying out clinical data management tasks.

- Delivers training to clinical data management and other departments, as necessary.

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DEPARTMENT

IT and Data Management

LOCATION

Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam

HOURS OF WORK

Full-time, 37.5 hours per week; extra hours may be required.

TENURE

Initially for 1 year, including a 2-month probation period, with the possibility of extension.

REPORTING TO

Head of IT and Data Management