Title:  Sr. Executive / Executive - Clinical Data Management

Job Purpose

• The incumbent is responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations

Key Roles and Responsibilities

• Effective management of all data management aspects of assigned project(s) from setup to lock.
• Attend regular meetings with project team, for discussions relating to data management issues and provides status updates for the project.
• Report on quality and performance metrics, including timelines, to project leads and other stakeholders
• Participate in in-house and external training courses, where required.
• Participate in the preparation/review of Data Management process control documents, including but not limited to Data Management Plan, Data Edit Checks Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, Reconciliation plans, CRF Completion Guidelines, Coding Guidelines, etc.
• Coordinate and manage training and EDC access for investigators, coordinators, data entry and CRAs on selected applications for data entry, cleaning, and running reports, as applicable to study parameters.
• Review, freeze and/or lock data in accordance with Data Management documents for accuracy, completeness, consistency and validity, generate queries, as necessary, for sites and/or project team.
• Coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.
• Maintain Data Management study documentation in an ‘audit-ready’ status,
• Perform reconciliation, including but not limited to SAS/AE, Electronic Data Files (EDF) and third-party data such as central labs and IVR, against the clinical database and track issues to resolution.
• May present at investigator meetings and PM/CRA training sessions.
• Identifies and recommends process improvements to management team, as identified.
• May work independently as a CDMPL on assigned projects.

Qualification, Skill and Competencies Requirements

• Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline.
• Minimum 3 years of clinical data management experience including working knowledge using clinical data capture tool.
• Experience with independently leading lobal clinical studies is preferred.