Responsibilities:

Ÿ Develop screens testing, edit check testing, and completion guidelines for selected project.

Ÿ Developing eCRF, annotating CRF, data validation plan for selected project.

Ÿ Developing, reviewing and managing the project plans for selected project: data manager plan,data manager report, etc.

Ÿ Developing, providing data transfers and incorporating data transfers from other sources for selected project.

Ÿ Managing database lock and unlock for selected project.

Ÿ Implement DMP changes to daily work activities, reference data issues log to resolve queries whenever possible, generate data queries; conduct quality control processes including Case Report Forms (CRFs) to database review.

Ÿ Perform data cleaning including query activity and Electronic Data Capture (EDC) reconciliation. Identify and report issues and data trends. Communication with regards to issues and concerns along with suggested resolution. Completion of assigned tasks in a timely manner meeting assigned goals for tasks. Run reports as requested and needed for daily tasks.

Ÿ Reconcile project files, reports, listings and other documents generated in data management against the EDC database for accuracy and completeness of data management processes.

Ÿ Perform all tasks to relevant company and/or Sponsor SOPs, ICH or other regulatory guidelines in Data Management.

Ÿ Act as DBP on trained EDC system, if needed.

Ÿ Perform other duties as required by the line manager.

Ÿ Take the responsibilities as follows in BA/BE studies:

a) Complete the work for BA/BE project.

b) Complete BA/BE project setup, conduct and closeout.

c) Make timeline, allocate work content reasonably, guide team members to complete tasks and ensure work quality, Finish it on time for BA/BE project.

d) Preparation and transfer of information as part of new project team members joining project.

Qualifications:

Ÿ BSc degree or above or equivalent education.

Ÿ Skilled in Microsoft applications.

Ÿ Basic understanding of medical terminology and clinical research terminology.

Ÿ Communicates effectively through both written and verbal methods.

Ÿ Understanding of ICH-GCP principles.

Ÿ Manage time effectively in order to produce quality deliverables in expected timeframe.