Spec Ii Pss

6 months ago

Pune Maharashtra, India Fortrea 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.

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.
- Monitoring eTMF compliance based on the eTMF filing plan and providing guidance to the Investigator site staff via raised queries in the BMS FastTrack communication portal
- Based on the Investigators enrolment plan, validate the initial drug supply demand and provide forecasting updates to BMS as required
- Support presentations for customer governance calls.
- Any other duties as assigned by management.

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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