Clinical Data Manager

325666BR
Aug 17, 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 key responsibilities:
Your responsibilities include, but are not limited to:

• As Clinical Data Manager (CDM) provide data management input on Clinical Trial teams. May have the role of TDM on small low complexity trials . 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) as applicable
• Manage local lab set up for the Clinical Database as applicable
• Under supervision ensures consistency of assigned trials with program level standards
• Understands third party data requirements and begins to gather an understanding of new technologies that may be used in the course of clinical trials
• Performs ongoing review of all data generated from the clinical study including Third party and local lab data as well as SAE reconciliation where applicable
• Ensures activities that are performed are done with quality and understanding of the process. Verifies and tracks eCRF completion including Query resolution and provides data status updates as needed
• With support from the Trial Data Manager develops proposals to resolve issues that may occur during the running of assigned trials. With support from the Trial Data Manager gives input into Study Specification worksheets should assigned trials need to be outsourced
• Has a working knowledge of FDA and ICH guidelines. Has proven ability to use the tools available to generate listings for data review and where necessary provides these to the study teams. Generates the study status reports for use at Clinical trial team meetings

Minimum Requirements

Global Drug Development
GDO GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
325666BR

Clinical Data Manager

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