Clinical Data Specialist

2 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.

Summary of Responsibilities:
• Ensures that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
• Demonstrates capability to read and follow study timelines for on-time deliverables.
• Potential to assist with inputs on study design or capable to make suggestions to study timelines when warranted.
• Assist with review of clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data.
• Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) used to support the review of clinical trial data.
• Generate, resolve and track queries to address problematic data identified during aggregate data review activities.
• Interacts 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.
• Generate and QCs data listings for internal data review.

• May 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.
• Demonstrates the ability to review Edit Check Specifications and Database specifications.
• Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
• Runs study status reports in preparation for Sponsor meetings and to deliver on specific 
Sponsor request.
• Assist with the completion of Database Lock and Unlock activities.
• Supports the training of new staff on project specific Data Management processes.
• Performs any other duties as assigned.

Qualifications (Minimum Required):
• University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited 
institution.
• Fluent in English, both written and verbal.


Experience (Minimum Required):
• 3 to 5 years of relevant work experience with increasing responsibility in data management with knowledge of one (1) or more therapeutic areas.
• Demonstrated time management skill and ability to adhere to project productivity metrics and timelines.
• Knowledge of medical terminology is preferred.
• Knowledge of effective clinical data management practices.
• Knowledge of science or a scientific background is preferred.
• Good oral and written communication skills.

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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