Global Late-Phase Trial Manager: Strategy & Delivery

IQVIA LLC; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

IQVIA is seeking a Senior Global Trial Manager to join our Single Sponsor Department. As a core Clinical Trial Team member, you will lead global studies, collaborate across functions, and drive late‑phase programs to meet timelines, budgets and quality standards.

You will oversee operational setup and maintenance, risk and issue management, regulatory documentation, CRO oversight, and budget planning, while engaging global stakeholders.

Qualifications

• Advanced degree in life sciences or healthcare.
• Minimum 5 years' experience in planning, executing and reporting global clinical trials in a pharmaceutical company or CRO, preferably including at least 2 years managing Real World Evidence (RWE) or global late-phase studies.
• Experience working in global, cross-functional matrix teams and building effective relationships with internal and external stakeholders.
• Ability to manage multiple studies or programs of work in parallel, consistently delivering to time, budget and quality expectations.
• Strong planning, communication, influencing, problem-solving and organisational skills, with the ability to work independently and manage ambiguity and change.
• A quality and compliance mindset, high attention to detail and the confidence to speak up, challenge constructively and drive issues to resolution.
• Experience contributing to relevant clinical study documents (e.g. protocols, PSURs, DSURs, regulatory submissions)

Responsibilities

• Plan, coordinate and oversee assigned Medical Affairs activities from operational set-up through maintenance, reporting and closure, ensuring deliverables and milestones are achieved on time and to the required quality standards.
• Act as the operational point of contact for assigned work and build productive relationships with global stakeholders, including Medical Affairs teams, study teams, investigators, external partners, reviewers, governance groups, CROs and other vendors.
• Develop, coordinate, review and maintain relevant study, program, submission and regulatory documentation, ensuring required inputs, approvals, decisions and records are complete and available in the appropriate systems.
• Coordinate the collection and timely completion of Global Medical Affairs inputs for program-level and safety documents, including DSURs, PSURs, Investigator Brochures, Addenda to Clinical Overviews and annual regulatory reports, where applicable.
• Organise and support kick-off, strategy, scientific review, governance and comment-resolution meetings, including preparation of pre-reads, agendas, supporting documentation, minutes, decisions and follow-up actions.
• Manage and maintain accurate operational information, trackers, panels, delegations, study or program status, metrics and reporting in relevant systems and databases.
• Plan and monitor budgets and resources, including investigational product or Post-Study Drug Supply forecasts where relevant, identifying impacts and escalating material changes for approval.
• Support the selection, contracting and oversight of CROs and third-party vendors, and monitor the performance of external partners where applicable.
• Identify, assess and manage operational, quality, compliance, GCP and delivery risks and issues; develop mitigation plans, elevate appropriately and support the timely completion of corrective and preventive actions.
• Monitor adherence to SOPs, working practices, GCP and other applicable requirements, maintaining audit and inspection readiness and supporting audit preparation, enquiries and corrective actions.
• Track assigned activities and outstanding items through to final resolution, ensuring timely execution, accurate reporting and effective communication of progress, decisions and dependencies.
• Contribute to process simplification, operational excellence, knowledge sharing and continuous improvement, promoting a strong culture of quality, integrity, collaboration and compliance.

Skills

Global trial management

Stakeholder management

Budget planning

Cross-functional collaboration

GCP compliance

Education

Advanced degree in life sciences or healthcare

Job description

IQVIA is seeking a Senior Global Trial Manager to join our Single Sponsor Department. As a core Clinical Trial Team member, you will lead global studies, collaborate across functions, and drive late‑phase programs to meet timelines, budgets and quality standards.

You will oversee operational setup and maintenance, risk and issue management, regulatory documentation, CRO oversight, and budget planning, while engaging global stakeholders.