Clinical Trials Manager
Category: Research & Development | Country: United States | State: California | City: Palo Alto| Type: Regular, Full Time | Job ID: 4635
Same job available at both sites
Palo Alto, California, United States
Philadelphia, Pennsylvania, United States
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and haematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Manager, Strategic Outsourcing will manage the clinical trial outsourcing, vendor selection and contract negotiation process for Jazz Pharmaceuticals’ clinical development programs.
Job Responsibilities and Requirements:
- Assist Senior Manager and senior leadership in the management of the outsourcing, vendor selection and clinical contracts process
- Generate RFPs, RFIs and contract templates
- Assist Clinical Trial Managers with quarterly internal budget forecasts of clinical projects Assist Senior Manager with Portfolio Planning process annually
- Negotiate and maintain clinical development contracts, including CDAs, MSAs, Investigator Meeting Letters, Work Orders for external clinical service providers, consultant agreements and speciality vendor contracts
- Oversee Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets are in line with study protocols
- Oversee CRO and Functional Service Provider activities in regards to site CDA’s and site contracts
- Submit purchase requisitions and manage contract approvals through the legal repository system
- Interface with cross-functional teams, including legal, 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 defence meetings as required
- Develop and maintain tracking tools spreadsheets, databases, etc.),
- Attend team meetings as appropriate; represent Strategic Outsourcing on CTWG meetings
- Assist in the monthly accrual process and financial reporting for projects
- Work in collaboration with Compliance on FMV; Review Aggregate Spend Tracker for Compliance
Bachelor’s degree with five years of general contract experience
- Experience in the pharmaceutical or biotechnology industry a plus
- Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
- Experience generating RFPs, RFIs, and study budget/contract templates
- Experience negotiating global 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 a plus
- Understanding of international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues a plus
- Working knowledge of financial terms and budgeting, 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
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.