Assoc Ii Pss

Labcorp Drug Development

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

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Job Description:
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.
- 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

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp 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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