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Clinical Data Associate Ii

3 weeks ago

Mumbai, India Fortrea - Organic 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.
- Clinical data review and identification of clinical data insights through patient level review, study level data review and trends analysis in order to ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study. Identification of data that are not clinically plausible and ensure relevant steps for resolution is in place.
- Supporting Interim Analysis, Database and Post Lock activities and facilitate resolution of clinical data issues.
- Identify data trend, analysis and remediation if any required to ensure clean and plausible data.
- identification of cases for medical review and adjudication and ensure relevant actions are taken for such cases.
- Collaboration with third party vendors with respect to lab data, adjudication data and other PRO data and ensure the data are clinically plausible.
- If assigned to a new study, requires contribution in development of Data Review/Quality Plan (DRP/DQP) and data review strategy. In conjunction with the relevant line functions, may contribute to Case Report Form (CRF) development, and support the implementation of data capture tools.
- Contribute to and facilitate data review process improvements e.g. identification of redundant reports and/or implementation of innovative data analysis processes and tools. Liaison with programmers in creating Patient Profiles and other summary reports to aid review process.
- Towards a study completion the additional activities would involve contribution to development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers and review of clinical trial documents for study CSR activities, and publications.
- As a part of CTT (Clinical Trial Team), requires participation in regular CTT meeting, Data Quality Team meeting, Safety Team Meetings, country calls etc
- Constant cross functional collaboration with other teams like Data management, Clinical Coding, Clinical Safety, Biostatistics and Trial Operations.
- Liaison with CRA's and country CSM's to rectify data issues and to clarify site queries on clinical data.
- Tracking and maintaining a track record of Protocol Deviations to identify if the deviations are within the Quality Tolerance Limit pre-set for the study.

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