Job Description

GREAT PLACE TO WORK - CERTIFIED

Summary of Position:

Provide timely and professional ongoing management of Data Management deliverables and of clinical trial data with respect to quality, timelines and costs for assigned trials within Clinical Data Management. Ensure consistently high quality data available for analysis and reporting.

Key Responsibilities:

• Provides DM support across assigned trial(s).
• Provides feedback to assure well-developed databases and data validation setup and execution while making the best use of standards and best practices
• Supports the team through database build requirements and complete startup activities for study including: building the eCRF, completion guidelines, standard and simple rules, data validation plan and user acceptance testing (UAT); can lead a study in sequence under PCDM supervision.
• Set up and Manage external data in accordance with protocol requirements, process and validation requirements
• Performs DM maintenance and validation activities during the course of the study timely and with quality.
• Tracks and reports status and progress for assigned trials and projects. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).
• Effectively communicates status updates and study level information to the Trial Data Manager (TDM) and Program Clinical Data Manager (PCDM)
• Provides support to business users and teams on their use and supporting the implementation of the Clinical Data Standards strategy.
• Ensures adherence to GCP, DM standards, SOPs/procedures, job aids and guidelines
• Maintain up-to-date, knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.

Key Requirements/Minimum Qualifications:

Achieve overall goals as set each year by Global Head, Data Management

All assigned project deliverables meet targets for quality, time and productivity in adherence with business standard operating procedures (No post production changes, no database unlocks).

No critical audit findings due to Data Management

University or college degree in life science, computer science, pharmacy, nursing, computer programming or equivalent relevant degree. Masters Preferred.

Ability to fluently read, write, understand, and communicate in English.

Work hours: 1 PM to 10 PM IST

Relocation assistance: Yes

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