Study Manager Job

STUDY MANAGER needed for a contract opportunity with Yoh's client located in Wilmington, DE.

The Big Picture - Top Skills You Should Possess:
- Study Operations
- Investigator Sponsored Studies (ISS)

What You'll Be Doing:
Manage local operational aspects of Investigator Sponsored Studies including:

- Drive local study operations (with investigator, study teams/medical directors, contracts)
- Facilitate ISS submissions, study performance, and ensure compliance to local regulations and procedures
- Lead local ISS review teams review of submissions (concepts, proposals, protocols)
- Local budget management, including forecasting & payments per contract to investigators
- Lead Quarterly Needs Assessment for ISS programs
- Provide product forecasts to Pharmaceutical Development
- Request drug shipments from Commercial or R&D Supply Chain
- Liaise with local health agencies/alliances (eg NCI)
- Monitor SAE reporting
- Facilitate review of ISS Report/Manuscript
- Support audits
- Close & archive study
- Primary capability is Driving Performance:
- Hold investigators accountable for fulfilling the terms of the contract, including recruitment updates, publications, and other deliverables
- Hold stakeholders accountable for following internal policies, HCP engagement guidelines, local regulations (eg CIA)

What You Need to Bring to the Table:
- Bachelor of Science degree in related discipline
- Experience in managing Investigator Sponsored Studies (ISSs)

OPPORTUNITY IS CALLING, APPLY NOW!

Yoh, a DayJ2W: CLINICAL

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