Senior I Clinical Programming Lead

Abiomed

4 - 9 years

7 - 11 Lacs

mumbai

Posted:4 hours ago| Platform:

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Skills Required

procurement computer science data analysis pharma process improvement clinical trials healthcare monitoring public health python

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for planning, programming strategy, coordination, oversight, and execution of team activities following J&J IM and industry standards for one or more clinical trials or projects.
Designs and develops programs in support of complex clinical data analysis and reporting activities.
Supports submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages and reviewer s guides.
Provides technical and project-specific guidance to team members, ensuring high-quality, efficiency and on-time deliverables in compliance with departmental processes and procedures. Ensures use of latest standards and deployment of current technologies.
Collaborates effectively with cross-functional team, counterparts, vendors to achieve project goals and manages escalations independently.
Supports submission activities while ensuring the highest level of consistency and quality across trials by creating efficiencies in clinical data flow and implementing metadata-driven approaches.
As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality.
May play the role of a Delivery Unit/Disease Area Expert contributing to standards strategy and providing expertise for a specific Delivery Unit/Disease area across value streams in support of clinical programs including submissions.

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