Clinical Data Specialist

3 - 7 years

0 Lacs

Posted:2 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a member of the project team at Fortrea, you will be responsible for conducting clinical data review, query generation/resolution, and reconciliation activities to ensure the delivery of clinical data meets client quality and integrity specifications, project timelines, and productivity targets. Your tasks will include assisting in developing the project Data Management Plan, executing data review guidelines/edit check, and eCRF specification, and contributing to the setup of data management systems based on project requirements. Your key responsibilities will involve: - Ensuring strict adherence to relevant protocols, global harmonized SOPs, and GCP standards for allocated projects. - Following study timelines for on-time deliverables and providing inputs on study design or timelines adjustments. - Reviewing clinical trial data, raising queries, and running additional programs to support data review. - Interacting with project team members for Data Management aspects setup, maintenance, and closure. - Generating and QC data listings, testing edit checks, database screen design, and functionality. - Supporting the training of new staff on project-specific Data Management processes. - Running study status reports, assisting in Database Lock and Unlock activities, and performing other assigned duties. Qualifications required: - University/college degree in life sciences, health sciences, information technology, or related fields, or certification in allied health professions. - Proficiency in English, both written and verbal. Experience required: - 3 to 5 years of relevant work experience in data management with knowledge of one or more therapeutic areas. - Demonstrated time management skills, knowledge of medical terminology, clinical data management practices, and effective communication skills. The job may involve working in an office or home-based environment, potential overtime, weekend work, and flexible shifts as per business requirements. Fortrea is dedicated to finding problem-solvers and creative thinkers who share a passion for overcoming clinical trial barriers. Join a collaborative workspace focused on revolutionizing the development process to deliver life-changing therapies swiftly to patients in need. Visit www.fortrea.com for more information. Fortrea is an Equal Opportunity Employer.,

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Fortrea logo
Fortrea

Pharmaceuticals

Durham

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