Manager, Clinical Outsourcing in Westminster

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.

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

Some limited travel may be required.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.