Snr Safety Science Specialist
5 months 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.
Job Summary:
Assist with the overall operations associated with the studies set-up, planning, and maintenance. The post holder is responsible for supporting team members in providing this service to Sponsor-Investigators either as a support function to the project groups. Responsible to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.Essential Job Duties:
Manage the set-up, planning, and maintenance of clinical studies in the client Portal Maintain a strong understanding of client conventions or client specific database conventions, as appropriate Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided Support/train/mentor less experienced safety staff in all aspects Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives Participate in project team and internal meetings, as appropriate Prepare and support coordination of ISR study files for archiving at completion of projects Ensuring that the IST investigator is providing study updates as applicable to the customer viz. regulatory updates, enrolment data, confirming that safety information is being transferred to customer as required, notification of any amendments to either the protocol or informed consent. Regular follow up with the customer POCs for updates on the protocol/study design. Cascading and tracking the same with the investigator. Ensuring that the agreed upon contractual milestones are being met and raising to customer for any threats to the milestones or if any milestones are missed Monitoring eTMF compliance based on the eTMF filing plan and providing guidance to the Investigator site staff via raised queries in the client communication portal Based on the Investigators enrolment plan, validate the initial drug supply demand and provide forecasting updates to client as required Support presentations for customer governance calls. 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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