Job Responsibilities

• Review study-specific protocols and design Case Report Forms (CRFs) for potential data collection utilizing Data Standards where possible.

• Assist in defining pre-programmed logical checks, with the testing of data entry screens and the preparation of the relevant database testing documentation.

• Create a CQC Plan which outline the CQC responsibility during all study stages and a detailed check list of applicable data outputs and processes to be reviewed and monitored periodically.

• Review the clinical database, in accordance to the CQC plan, to ensure the accuracy, reliability, integrity, consistency and completeness of the whole database

• Train staff in RDC data recording, CRF completion and RDC discrepancy management.

• Code, QC and supervise coding activities of medical history, adverse events, and concomitant medications. • Perform Serious Adverse Event reconciliation.

• Report status of CQC activities to intra-/inter-departmental colleagues and senior management.

• Interface with vendors, CRO’s and/or outsourcing organizations

• Coordinate and share knowledge with Global DM members and Outsourced teams.

• Support the establishment of training programs and ensure staff training is conducted and properly documented.

Job Requirements

• Bachelor or higher degree in a Science-related field or medical field.

• At least 8-10 years of pharmaceutical experience.

• Good management and leadership skills, with at least one year of team management experience.

• Ability to mentor, coach within CQC and cross functionally, and train internal and external training.

• Interpersonal communication and interaction skills.