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Jazz Pharmaceuticals · 6 days ago

Senior Manager, Clinical Outsourcing

United States

Full-time

Remote

Senior Level

$142K/yr - $212K/yr

5+ years exp

Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for serious diseases. The Senior Manager, Clinical Outsourcing will lead and manage clinical trial outsourcing, overseeing vendor evaluation, selection, contract negotiation, and relationship management to support clinical development programs.

BiotechnologyHealth CarePharmaceutical

No H1B

Responsibilities

Collaborates with cross-functional (Legal, Finance, FP&A, Clinical Operations, etc.) departments relating to developing and managing vendor contracts and budgets and managing vendor performance

Collaborates with vendors to proactively manage risk, resolve issues, address questions, and optimize ways of working as outsourcing partners

Leads the vendor evaluation and selection process in accordance with clinical outsourcing and clinical sub-category strategies, partnering with internal Jazz stakeholders and cross-functional business partners

Generates RFPs, RFIs and contract templates in support of the clinical outsourcing process and in compliance with standard operating procedures and policies

Negotiates clinical vendor contracts and budgets, including MSAs and statement of work (SOWs) for CROs and other clinical category vendors

Acts as an issue escalation point for study teams managing and escalating vendor performance issues, as required and in accordance with vendor governance charters and established issue escalation pathways

Represents Clinical Outsourcing to cross-functional teams/clinical trial working groups, coaching R&D on current processes and policies as it relates to Clinical Outsourcing and the clinical contracts process, as required

Submits and manages purchase requisitions and contracts through the approval process in Jazz’s S2P system

May lead or participate in departmental initiatives/projects in support of Jazz R&D and/or Global Procurement

May develop and lead clinical sub-category strategy(s) and key vendor relationship(s)

May lead or support vendor governance activities, as required

May supervise and contribute to the training and professional development of staff

Qualification

Clinical outsourcingVendor managementContract negotiationDrug development processClinical trial functionsRFPsRFIs developmentCompliance knowledgeCross-functional collaborationOncology experienceNeurology experienceProject managementInterpersonal communicationTime management

Required

Minimum 5 years of clinical outsourcing experience

Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization

Must have a comprehensive understanding of the drug development process

Working knowledge of clinical trial functions, including clinical operations, data management, biostatistics, regulatory and drug safety

Experience collaborating cross-functionally to develop RFPs, RFIs, and study budget/contract templates

Proven track record negotiating complex clinical services 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 managing CROs, central laboratories, and other clinical study vendor relationships

Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues

Demonstrated strength in time and project management with the ability to prioritize and handle multiple competing tasks simultaneously and under pressure

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

Bachelor's degree required