Spec I Pss

7 days 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.

Roles & Responsibilities:

- 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
- Impart process trainings within the team for sign off and refresher trainings as applicable
- Supporting the leads on preparation of the dashboards as required on a regular interval
- 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 BMS FastTrack communication portal
- Based on the Investigators enrolment plan, validate the initial drug supply demand and provide forecasting updates to BMS as required
- Review Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guideline.
- Review protocol and protocol amendments to assure compliance with sponsor requirements, reconfirm completeness and to assure compliance with Good Clinical Practice (GCP) guidelines
- Support presentations for customer governance calls

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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