Global Study Leader

Jazz Pharmaceuticals; Palo Alto (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

Jazz Pharmaceuticals is a global biopharma company focused on transforming patient lives through innovative medicines. The role oversees global clinical trials, leading cross-functional teams, ensuring regulatory compliance, and driving trial strategies from startup to completion.

A strong leadership track record in multi-center trials and expertise in TMF/CTMS is essential. Based in Palo Alto, this position emphasizes strategic oversight of trial timelines, budgets and vendor management, with

Qualifications

• 7+ years of clinical research experience with global trial management.
• Minimum of 3 years in clinical operations leadership roles.
• Excellent organizational, time-management and attention to detail.
• Excellent written and verbal communication skills and stakeholder management.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Experience with Clinical Trial electronic systems (TMF, CTMS).
• Strong knowledge of ICH-GCP and regulatory requirements.
• Knowledge of regulatory start-up processes and SSU.
• Proven track record of cross-functional leadership in global trials.
• Strong project management and governance skills.
• Willingness to travel 10–20% domestically and internationally.

Responsibilities

• Provide oversight to ensure study delivery and operational excellence.
• Delegate tasks to study team members as appropriate.
• Lead implementation, execution and management of global Phase I-IV clinical trials.
• Lead trial-related meetings and align with cross-functional teams.
• Act as escalation point for cross-functional stakeholders for timely resolution.
• Participate in program-level discussions and provide updates to senior management.
• Develop and execute clinical trial strategies throughout the lifecycle.
• Hold accountability for the Trial Master File (TMF) and act as SME.
• Develop and review trial-specific plans and essential documents.
• Review and approve protocols, ICFs, monitoring plans, CSRs.
• Contribute to feasibility, vendor selection, recruitment strategies and budgeting.
• Plan Investigator Meetings and deliver key trial messages.
• Identify and manage risk to protect timelines and quality.
• Track timelines and budgets, analyze vendor spend.
• Oversee external service providers to ensure quality and compliance.
• Oversee trial tracking in TMF/CTMS and archiving.
• Serve as trial lead during audits and inspections.
• Coordinate IMP shipment authorization with regulatory functions.
• Support data query processes and monitoring visit reports.
• Lead and participate in GCDO initiatives and process design.

Skills

Clinical trial management

Global portfolio oversight

Leadership

Stakeholder management

GCP & regulatory

CTMS / TMF systems

Project management

Communication skills

MS Office

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

CTMS

TMF

Job description

If you are a current Jazz employee please apply via the Internal Career site.

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. Please visit www.jazzpharmaceuticals.com for more information.

Essential Functions /Responsibilities

• In partnership with the study team and internal and external service providers, provides oversight to ensure study delivery and ensure operational excellence.
• Delegate tasks to study team members as appropriate.
• Lead implementation, execution and management of global Phase I-IV clinical trials.
• Lead, facilitate and delegate trial-related meetings, ensuring alignment with cross-functional teams.
• Act as a primary point of escalation for cross-functional stakeholders for timely issue resolution and alignment.
• Participate in program-level discussions (FMT, GPT), providing clear and timely updates to senior management (as needed).
• Develop and execute clinical trial strategies in collaboration with cross-functional teams during the trial lifecycle including tracking and reporting trial progress, risks and mitigation strategies to senior leadership.
• Hold overall accountability for the Trial Master File (TMF). Acts as an SME for Clinical Operations related sections.
• Lead the development and review of trial-specific plans and essential clinical trial documents.
• Review and approve key trial documents including protocols, informed consent forms, monitoring plans, and Clinical Study Reports (CSRs) in line with Standard Operating Procedures (SOPs).
• Actively contribute s to the operational oversight and strategic direction of assigned studies, including feasibility assessments, planning, vendor selection, patient recruitment strategies, and financial forecasting.
• Contribute to the planning and conduct of Investigator Meetings, including driving meeting preparation, presenting trial materials, and supporting effective delivery of key messages.
• Identify, assess, and proactively manage risk and contingencies to safeguard timelines, quality and compliance.
• Develop, manage and track trial timelines and budgets, in line with projected spend. Estimate, track and critically analyze vendor financial spend on trials.
• Accountable for the oversight and management of external service providers and vendors to ensure quality, compliance, and performance.
• Oversee trial tracking activities and ensure accurate, timely updates within trial management systems.
• Accountable for final approval and oversight of trial documentation archiving in compliance with regulatory and company requirements.
• Serve as trial lead and SME during audits and inspections.
• Coordinate Investigational Medicinal Product (IMP) shipment authorization with regulatory and clinical supplies functions.
• Assist and support data query process.
• Perform monitoring visit report review (as required).
• Lead and participate in Clinical Operations / Global Clinical Development Operations (GCDO) initiatives (as assigned).
• Serves as a Clinical Operations SME in the design and review of processes.
• Ensure trial activities are conducted according to GCP and relevant SOPs and in accordance with the agreed timelines and trial protocol.

Leadership / People Management Responsibilities:

• Mentor and coach Global Study Managers (GSMs) Clinical Research Associates (CRAs), and Global Study Associates (GSAs) to support professional development.
• Lead Clinical Trial Working Groups (CTWG)s.
• Provide leadership in resolving complex trial issues and escalating risks appropriately.
• Manage and maintain high performing clinical teams.

Required Knowledge, Skills, and Abilities

• 7+ years of clinical research experience, with proven global trial management and portfolio-level oversight with a minimum of 3 years in clinical operations leadership roles.
• Excellent organizational skills, time-management and attention to detail.
• Excellent written and verbal communication skills and stakeholder management abilities.
• Ability to work both independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Experience with and strong knowledge of Clinical Trial electronic systems (e.g., TMF, Clinical Trial Management System (CTMS), etc.).
• Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements.
• Strong knowledge of regulatory start up process and planning in support of Study Startup-U p (SSU).
• Proven track record of effectively managing in a cross-functional environment.
• Excellent project management skills with a proven track record of managing global, multi-center clinical trials.
• Strong leadership and governance experience; ability to influence at senior levels.
• 10% to 20%Domestic and International travel.

Required/Preferred Education and Licenses

• Bachelor's degree, preferably in life sciences, healthcare, or a related field, or equivalent experience.
• Advanced degree preferred.

#LI-DM1

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.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $140,000.00 - $210,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence