Manager, Clinical Outsourcing

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