Job Description

Brief Description:

The Global Study Leader (GSL) leads global Phase I-IV clinical trials, overseeing strategy, execution and cross-functional alignment. They manage vendors, budgets, timelines, and documentation and serve as a Subject Matter Expert (SME) in audits, process design, and team leadership, ensuring Good Clinical Practice (GCP) compliance and operational excellence across studies.

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 contributes 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.
Serves 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 (CTWGs).
- Provide leadership in resolving complex trial issues and escalating risks appropriately.
- Manage and maintain high performing clinical teams.

Required Knowledge, Skills, and Abilities

Clinical research experience, with proven global trial management and portfolio-level oversight with experience 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 Start-Up (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.

Required/Preferred Education and Licenses

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

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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:
$145,600.00 - $218,400.00

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 individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k 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

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