Global Study Leader

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

Job summary

Jazz Pharmaceuticals seeks an experienced Clinical Operations Leader to oversee global Phase I–IV trials, ensure delivery, and maintain the Trial Master File (TMF). You will mentor GSMs, CRAs, and GSAs, and align cross-functional teams to meet timelines and budgets.

The role requires 7+ years in clinical research with leadership and strong regulatory knowledge, plus proficiency with TMF/CTMS systems and 10–20% travel. Bachelor's degree is required; advanced degree preferred.

Qualifications

• 7+ years of clinical research experience with global trial oversight.
• Experience in clinical operations leadership roles.
• Excellent organizational and communication skills.
• Proven ability to work independently and cross-functionally.
• Strong knowledge of ICH-GCP and regulatory requirements.

Responsibilities

• Oversee global Phase I–IV trials and ensure delivery to plan.
• Lead meetings, delegate tasks, and provide escalation as needed.
• Manage TMF and trial documentation per SOPs.
• Develop trial strategies, timelines, and budgets with cross-functional teams.
• Mentor GSMs/CRAs/GSAs and lead Clinical Trial Working Groups.
• Coordinate Investigator Meetings and vendor relationships.

Skills

Clinical Operations Leadership

Global Study Management

Project Management

Regulatory Knowledge

GCP Compliance

Vendor Management

Cross-functional Leadership

Education

Bachelor's degree in life sciences or related field

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