US-Clinical Study Manager
A10 - Durham, NC

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Location :
Durham, NC

Position Type : Contract

Experience Level :
Start Date / End Date : 04/30/2012 / 10/29/2012

Description

Position is in Respiratory

Accountable to ensure all relevant studies follow company SOPs and GCP.

Assist with maintaining relationships and monitor performance of CROs and other vendors.

With direction from Senior Clinical Staff, collaborate with Clinical Operations functional groups (US Monitoring, Data Management, and Operations Management) to ensure on time delivery of studies.

Proactively track timelines; identify issues and propose strategies to implement contingencies and risk planning to meet overall study goals.

Manage study start-up, conduct and close-out.

Manage and forecast clinical trial material.

Manage clinical trial budgets to include: develop initial budget, review and approve invoices, manage monthly accruals, utilize existing company tools to benchmark and manage study costs, review and update monthly budget phasing (spend), provide explanation for budget variances, develop and retain budget assumptions.

Assist in the management of CROs or other outsourcing partners as appropriate

Provide input into content and execution of investigator meetings - may present selected topics.

Coordinate presentation materials from cross functional areas for PI meetings.

Provide input into development of CRF.

Provide input into site selection.

Review and approve country/site start up and patient recruitment plans.

Manage collection of operational feasibility for study design

Keep internal tracking systems accurate and up to date; extract and use data to manage assigned studies

Experience setting up contracts with and managing electronic data capture tools and./or systems (eCRF, eDiary, Holter monitoring, etc.)

Previous experience managing vendors

Skills:
Communication- oral and written
Resilience
Flexibility, Adaptability
Initiative
Team player
Ability to work in environment with multiple priorities and frequent changes

Technical Skills:
4 year degree preferred
Computer skills proficiency (Lotus Notes, MicroSoft Office suite)

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