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Safety Science Specialist
2 weeks ago
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:
Support ISR Management team during study set-up, planning, and maintenance of ISRs projects in the ISR Portal Management of study trackers, document management (eTMF, archiving), SharePoint sites and other client's systems Supports inspection readiness through quality control Participates in internal improvement projects Manages and prioritizes activities; seeks guidance as appropriate/if needed Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided Maintain a strong understanding of BMS's ISR conventions or client specific database conventions, as appropriate Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with ISR Participate in ISR project team and internal meetings, as appropriate Prepare and support coordination of ISR study files for archiving at completion of projects Generate and distribute management reports in accurate and timely manner. Perform data analysis for generating reports on periodic basis. Provide strong reporting and analytical information support to management team. Generate both periodic and ad hoc reports as needed. Provide customer support and assistance in issue troubleshooting and resolution. Any other duties as assigned by management.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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