Manager, Clinical outsourcing

Jollyes Pets; High Wych; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in the UK seeks a Manager for Clinical Outsourcing to manage clinical trial outsourcing for its development programs. Responsibilities include vendor selection, contract negotiation, and financial management processes. The ideal candidate will have a Bachelor's degree and over three years of clinical outsourcing experience. Excellent communication skills and experience with clinical trial compliance are also required. The role involves collaboration with cross-functional teams and offers benefits including medical and retirement options.

Benefits

Medical insurance

Dental insurance

Vision insurance

Retirement savings plan

Flexible paid vacation

Qualifications

• 3+ years of clinical outsourcing experience.
• Proven track record of negotiating contracts.
• In-depth knowledge of compliance and legal issues.

Responsibilities

• Manage the clinical trial outsourcing process.
• Develop and maintain vendor relationships.
• Negotiate and maintain clinical contracts.
• Assist in monthly financial reporting.

Skills

Clinical outsourcing experience

Excellent communication skills

Contract negotiation

Vendor management

Education

Bachelor’s degree

Job 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's clinical studies.

Key Responsibilities

• 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 regards 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
• Organise bid defence meetings as required
• Develop and maintain tracking tools (spreadsheets, databases, etc.)
• Attend team meetings as appropriate, representing 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

Qualifications

• 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 phases 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 prioritise and handle multiple tasks simultaneously
• Maintain up‑to‑date information on changing healthcare regulations affecting clinical trial payments
• Some limited travel may be required

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, a retirement savings plan, and flexible paid vacation. For more information on our benefits offerings please click here: https://careers.Jazzpharma.Com/benefits.Html.

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.