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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