Sr Clinical Data Analyst

3 weeks ago

Bangalore, India Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Essential Job Duties:
 Ensures that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
 Perform all data management tasks as appropriate to include, but not to be limited to data review and query management to ensure that quality standards (both internal and client) are achieved within stipulated timelines.
 Assist with reviewing clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data.
 Generate, resolve and track queries to address problematic data identified during aggregate data review activities.
 Run and execute additional programs, special listings, reconciliation discrepancy listings etc.) used to support the review of clinical trial data.
 Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required.
 Assist with review of data listings for internal data review.
 Assist or create dummy data to test edit checks and to test database screen design and functionality.
 Assist or create dummy data to test SAS reports and data listing.
 Modify standard templates to create study specific Data Management Plans, or eCRF completion guidelines.
 Support team members by creating forms/memos as required.
 Posting of Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
 Generate study status reports.
 Perform database extracts.
 Assist in the creation of slides for Investigator Meeting and Site Initiation Visit or similar meetings.
 Assist with the completion of Database Lock activities.
 Support the training of new staff on project specific Data Management processes.
 Performs any other duties as assigned.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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