Brief Description
The Manager, Clinical outsourcing will manage the clinical trial outsourcing for Jazz Pharmaceuticals' clinical development programs across clinical study phases pre- and post-authorization. Under the direction of the Associate Director, Clinical Outsourcing s/he is responsible for the vendor evaluation and selection, contract negotiation and maintenance, and financial management processes in support of Jazz' clinical studies.
Essential Functions
* Assist Associate Director and senior leadership in the management of the outsourcing, vendor selection and clinical contracts process
* Generate RFIs, RFPs, and contract templates
* Negotiate and maintain clinical development contracts, including vendor CDAs, MSAs,, investigator meeting agreements, Statements of Works for external clinical service providers, consultant agreements and specialty vendor contracts
* Oversee CRO/FSP activities in regard to CDAs, vendor Statements of Work and clinical site agreements
* Submit purchase requisitions and manage contract approvals through Jazz's S2P system
* Interface with cross-functional teams, including legal, procurement, compliance and clinical operations functions in selection and management of vendors and study sites
* Manage selection process and develop strong relationships with vendors in conjunction with cross-functional teams
* Organize bid defense meetings as required
* Develop and maintain tracking tools (spreadsheets, databases, etc.)
* Attend team meetings as appropriate, represent Clinical outsourcing on cross-functional clinical trial working group meetings.
* Assist in the monthly accrual process and financial reporting for projects
* Assist Director with departmental process improvements as needed
* Work in collaboration with Compliance on FMV;
* May help train individual contributor/professional employees
Required Knowledge, Skills, and Abilities
* Bachelor's degree with three years of clinical outsourcing experience
* Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
* Experience generating RFPs, RFIs, and study budget/contract templates
* Proven track record negotiating contracts and budgets with both U.S. and international vendors
* In-depth knowledge of compliance and legal issues related to the conduct of clinical trials phase 1 - 3. Experience with post authorization phase 4 preferred.
* Experience managing CROs, central laboratories, and other clinical study vendors, including trial sites a plus.
* Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues
* Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety
* Ability to prioritize and handle multiple tasks simultaneously
* Maintain up to date information on changing healthcare regulations affecting clinical trial payments
* Jazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence This is highly valued in our employees.
* Some limited travel may be required
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