Fortrea Clinical Data Specialist Opportunity in Bangalore

Fortrea Hiring Clinical Data Specialist in Bangalore

Fortrea, a leading global contract research organization (CRO), is seeking a highly skilled and motivated Clinical Data Specialist to join their team in Bangalore. With over 19,000 staff members conducting operations in more than 90 countries, Fortrea is dedicated to transforming drug and device development for partners and patients across the globe.

About Fortrea

Fortrea specializes in providing pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions. The company operates in over 20 therapeutic areas and is committed to scientific rigor and innovative clinical development practices.

Job Details

Position: Clinical Data Specialist
Location: Bangalore, India
Experience Required: 3-5 years in data management

Responsibilities

• Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
• Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
• Generate, resolve and track queries to address problematic data identified during data review activities.
• Perform aggregate review of clinical data by patient, site and / or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that require further investigation.
• Apply quality control procedures and checks to ensure data quality standards (client and Fortrea) are achieved.
• Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRF Completion guidelines, Data Management Plans, Perform Data review utilizing all applicable documents such as protocols, CRFs (or eCRFs and eDiary) etc.
• Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
• Assist in the review of the database design and annotate the CRF (eCRF) according to the specifications.
• Create and assist in the data review guidelines, make sure to be consistent with the clinical data model, and CRF/eCRF completion / monitoring conventions.
• Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
• May assist with the Lead Data Manager or Lead Data Reviewer to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary.
• Knowledge of Data Management tools, systems, and processes.
• Ensures service and quality, meet agreed upon specifications per the DMP and scope of work in the budget.
• Inform Lead Data Reviewer of overages in budgeted units and assist in Change Order Log process, if applicable.
• Perform quality control on data management activities as appropriate to include, but not be limited to all study documentation, query generation and integration; to ensure that internal and client quality standards are achieved.
• Support and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team, as appropriate.
• Mentor / Coach in training of project staff on project-specific, global, standardized data management processes.
• Performs other related duties as assigned by management.

Qualifications

• Education: University/college degree in life sciences, health sciences, information technology, or a related field, or certification in allied health professions from an accredited institution.
• Experience: 3-5 years of relevant work experience in data management, with knowledge of one or more therapeutic areas.
• Skills: Knowledge of effective clinical data management practices and medical terminology is preferred. Strong time management skills and the ability to adhere to project productivity metrics and timelines are essential.
• Language: Fluent in English, both written and verbal.

How to Apply

Interested candidates are encouraged to apply by visiting Fortrea’s career page and submitting resumes.

Tagged as: Global Pharma Jobs, Good Clinical Practice (GCP), Pharmaceutical Careers, Pharmaceutical Jobs