Title:  Clinical Data Programming

JOB DESCRIPTION

Form074230-V1.0, ED:29-Mar-2024

Job Role Name

Clinical Database Programmer (CDP)

Department Name

Global Clinical Data Management (GCDM)

Job Purpose

• The incumbent manages Clinical Data Programming to ensure timely creation, validation, testing, implementation and maintenance of databases required across all assigned projects.
• Analyzes study protocol and project requirement(s), identifies data quality rules, and design data entry interfaces in accordance to the study Protocol, DMP, SOP and all applicable regulatory requirements and standards.

Key Roles and Responsibilities

• Deploy complete, accurate and efficient clinical study database(s) for the purpose of Data Management and Data processing.
• Support and ensure the preparation, transfer and integration of clinical data from internal and external sources into the clinical study database. Provide clinical study data in various formats and applications to all critical project stake holders, as required.
• Ensure high quality deliverables, good cooperation with internal and external project stake holders and active participation in project teams to develop and maintain programs to meet project standards.
• Responsible for data exchange with external project stake holders, for example, third party vendors (Labs, ECG, etc.) and Safety / Independent Data Monitoring Committees, as required.
• Provide ongoing day to day end-user support to the project team(s) to ensure all systems and programs are executing correct and efficiently.
• Setup and support of data review and reporting tools required by DM stakeholders SAS programmers, Clinical, Medical, Pharmacovigilance and Regulatory Affairs and where required by the Study Management Team.
• Provide technical expertise and programming support for projects and data management staff.
• Communicate project status and key project issues to DM Management.
• Assist in developing new Data Systems programming procedures and processes.
• Keeps current with technological advances and coordinates activities with Global Training and Information Technology Team in an effort to maximize their potential use in managing data.
• Provide mentoring and training of other while assist in work delegation.
• Supports, maintains and utilizes standardization of CRF and eCRF modules, data quality rules, data structures, data libraries, code lists, and dictionaries in conjunction with input from other functional areas and project teams and in accordance with CDISC standards.
• May take part in evaluating external vendors and technologies as to their ability to perform in accordance to project goals, procedures, and quality standards prior to project scope finalization.
• Identifies areas of process improvement that may be provided by standardization and/or technology to increase efficiency, quality and timeliness of data management processes and deliverables.

Qualification, Skill and Competencies Requirements

• Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline.
• Minimum 8-10 years of clinical data programming experience including working knowledge using clinical data programming tools and applications.
• Experience of leading clinical programming effort across global clinical studies is preferred.

Job Location

Gurugram, HR

Reporting To

Clinical Database Programming Lead (CDPL)