Clinical Research Organization Manager
Roche Diagnostics - Indiana

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The Manager, Clinical Research Organizations (CRO), identifies and engages CRO resources and capabilities utilizing external resources to achieve production of high quality data to support the goals of projects in Medical Scientific Affairs (MSA). This position works proactively in cooperation with all MSA functions, e.g. Global Medical Leader, Scientific Affairs Manager, Study Manager, CRAS, Study support and Study Concepts to identify preferred CROs for project consideration; defines the work specifications together with the Study Manager and prepares request for proposal, manages the competitive bidding process, and selects the optimal CRO with respect to quality, resources and time factors; and participates in managing and overseeing the activities of contracted CRO as per separate roles and responsibilities document prepared for each outsourcing activity. CRO Manager has operational leadership responsibility, with high impact of work on the organization; achieves results through the management of subordinates (professional and support staff); and establishes and manages the department's budget and all assigned resources Additional responsibilities include:
• Identifies, develops and maintains relationships with preferred vendors that are compatible with our systems and can operate within our procedures or with their own procedures with respect to quality standards and regulatory requirements
• Establishes CRO and Roche roles and responsibilities as well as pricing for contracted projects by working with Contracting, Procurement, Legal and Quality groups. Drive to fair market value for projects by using the procurement benchmarking tools.
• Manages the competitive bidding and selection process. Assess the quotations submitted and selects the vendors which fit the commercial/financial needs of the study to be conducted.
• Participates in managing and overseeing the activities of contracted CRO as per roles and responsibilities prepared for each study
• Reviews and communicates Key Performance Indicators (KPIs) to upper managementResponsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

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Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...