Global Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based

Lifelancer Ltd; EUA; Teletrabalho; USD 120 000 - 173 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Senior Global Trial Manager to lead late-phase studies in a single sponsor setting. The role is home-based with international scope, requiring strong cross-functional collaboration across data management, drug supply, regulatory, and medical writing.

You will own study delivery, ensure timelines and budgets are met, and oversee TMF readiness, safety updates, and regulatory submissions while championing data quality and real-world evidence generation.

Qualificações

• Experience managing Phase IV, PASS, PAES, or NIS trials.
• Proven ability to lead protocol development and trial startup.
• Strong regulatory writing experience.
• Excellent communication and collaboration skills.
• Deep understanding of GCP and clinical trial design.

Responsabilidades

• Draft sections of protocols, CRFs, training materials, and data review plans.
• Oversee data review and TMF audit readiness.
• Forecast and manage investigational product supply.
• Support study closeout, issue resolution, and lifecycle budget tracking.
• Coordinate CRO/vendor selection and performance.

Conhecimentos

Global trial management

Protocol development

Regulatory writing

Communication skills

GCP knowledge

Formação académica

Advanced degree in life sciences or healthcare

Descrição da oferta de emprego

Job Title: Global Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based

Job Location: Reading, Berkshire, United Kingdom

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Senior Global Trial Manager – Single SponsorAre you experienced in managing late phase clinical trials at a global level?

We are looking for a Senior Global Trial Manager to join our Single Sponsor Department.

Join our global team and take ownership of delivering late-phase clinical trials that meet timelines, budgets, and quality standards. As a core Clinical Trial Team (CTT) member, you’ll lead critical aspects of global studies and collaborate across functions to drive success.

As part of your role, you’ll have the opportunity to specialise in one for the following areas:

• Scientific Review Committee (SRC)
• Non-Interventional Studies (NIS)
• Managed Access Programs (MAP)
• Investigator-Initiated Trials (IITs)
• Research Collaborations (RCs)
• Program Level Documents (PLD)

Key Responsibilities

Clinical Documentation & Study Tools

• Draft sections of protocols, CRFs, training materials, and data review plans
• Contribute to the development of safety updates, IBs, and regulatory submissions

Project Leadership

• Oversee data review and TMF audit readiness
• Forecast/manage investigational product supply
• Support study closeout, issue resolution, and lifecycle budget tracking
• Contribute to Managed Access Program coordination and compliance

Vendor & Stakeholder Management

• Coordinate CRO/vendor selection and performance
• Facilitate advisory boards (DMCs/Steering Committees) and serve as the site liaison
• Lead cross-functional collaboration with data management, drug supply, and more

What You'll Bring

• Advanced degree in life sciences or healthcare
• 2–5 years' global experience managing phase IV, PASS, PAES, or NIS trials
• Strong track record in protocol development, study startup, and regulatory writing (e.g. PSURs, DSURs, NDA/BLA reports)
• Excellent communication, organizational, and collaboration skills
• Deep understanding of GCP and clinical trial design
• Passion for advancing real-world evidence and patient outcomes

Please note this role is not eligible for the UK visa sponsorship.

Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at .

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.