Job Location: Bengaluru
GREAT PLACE TO WORK – CERTIFIED
Summary of Position:
Responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality and timelines for all assigned indications within one or more Project(s). Coaches TDMs to provide leadership to project/study teams. Ensure consistency across assigned program and global standards to aid in efficiencies and quality. Provide active and effective communication to CTT, PCDM, Global Program teams, DO DUs and other stakeholder groups.
Key Responsibilities:
- Provides Data Management leadership for one or more assigned programs/projects or indications, simultaneously leading and multiple concurrent trials.
- Demonstrates a business understanding of the portfolio, products and indication to identify and assist in successful application of data management processes
- Provides feedback to assure well-written protocols. Recognize and resolve protocol issues that may impact database design, data validation, data integrity and/or analysis/reporting while making the best use of standards and best practices
- 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 and overseas and ensures quality where support services are provided.
- 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).
- Coaches and mentors associates as required, ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution.
- Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence
- 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.
- 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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You are applying to be part of the Alcon Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV or resume.
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