Senior Clinical Data Manager

326383BR
Aug 30, 2021
India

Job Description

500 studies across multiple therapeutic areas. This is the exposure and scale our Data Management group has. We are on our journey to Reimagine medicine with Data and Digital and our team is focused on delivering data which is fit for purpose.
Innovation at scale is one of the strategic pillars for us as a Clinical Data Management team and you will have an opportunity to apply your skills to experiment and innovate ways to transform the Clinical Data Management process in Drug Development.
We are looking for individuals with end to end experience in clinical data management. You will play a key role in providing leadership to various teams and developing cross-functional data cleaning strategies.

Your responsibilities include, but are not limited to:

• Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager where needed. Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes.

• Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards

• Performs DM activities for start up of a study including preparing the eCRF, CCG’s where needed, Data Handling plan (DHP), Data Review Plan (DRP) and performing user acceptance testing (UAT). Manage local lab set up for the Clinical Database as applicable

• Performs DM hands on activities during the course of the study. Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)

• Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation. Supports and assists Junior staff for assigned trials

• Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner

• Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence. Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks). Ensures adherence to GCP, DM standards, SOPs/WPS and process guidelines

Minimum Requirements

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Global Drug Development
GDO GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
326383BR

Senior Clinical Data Manager

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