Senior Global Late-Phase Trial Lead

IQVIA; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

IQVIA seeks a Senior Global Trial Manager to lead late-phase trials in the Single Sponsor Department. You will guide global studies, coordinate with Medical Affairs, study teams, investigators and CROs to ensure on-time delivery, quality, and compliant submission documents.

This role emphasizes strategic planning, stakeholder management, risk mitigation, and continuous-improvement within a matrix, cross-functional environment across multiple pathways (SRC, MAP, IITs, NIS, RCs, PLD).

Qualifications

• Minimum 5 years’ experience in planning, executing and reporting global clinical trials.
• Experience in global, cross-functional matrix teams and building relationships with stakeholders.
• Ability to manage multiple studies in parallel, delivering on time and within budget.
• Strong planning, communication, influencing, problem-solving and organisational skills.
• Experience contributing to clinical study documents (e.g. protocols, PSURs, DSURs).

Responsibilities

• Plan,coordinateand 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 andmaintainrelevant study,program, submission and regulatory documentation, ensuring required inputs, approvals,decisionsand records are complete and available in theappropriate systems.
• Coordinate the collection andtimelycompletion of Global Medical Affairs inputs forprogram-level and safety documents, including DSURs, PSURs, Investigator Brochures, Addenda to Clinical Overviews and annual regulatory reports, where applicable.
• Organiseand support kick-off, strategy, scientific review,governanceand comment-resolution meetings, including preparation of pre-reads, agendas, supporting documentation, minutes,decisionsand follow-up actions.
• Manage andmaintainaccurateoperational information, trackers, panels, delegations, study orprogramstatus,metricsand reporting in relevant systems and databases.
• Plan andmonitorbudgets and resources, including investigational product or Post-Study Drug Supply forecasts where relevant,identifyingimpacts and escalating material changes for approval.
• Support the selection, contracting and oversight of CROs and third-party vendors, andmonitorthe performance of external partners where applicable.
• Identify,assessand manage operational, quality, compliance,GCPand delivery risks and issues; develop mitigation plans, expediteappropriateand support thetimelycompletion of corrective and preventive actions.
• Monitor adherence to SOPs, working practices, GCP and other applicable requirements,maintainingaudit andinspectionreadiness and supporting audit preparation,enquiriesand corrective actions.
• Track assigned activities and outstanding items through to final resolution, ensuringtimelyexecution,accuratereporting and effective communication of progress,decisionsand dependencies.
• Contribute to process simplification, operational excellence, knowledge sharing and continuous improvement, promoting a strong culture of quality, integrity,collaborationand compliance.

Skills

Stakeholder management

Planning

Communication

Risk management

Data accuracy

Education

Advanced degree in life sciences or healthcare

Job description

IQVIA seeks a Senior Global Trial Manager to lead late-phase trials in the Single Sponsor Department. You will guide global studies, coordinate with Medical Affairs, study teams, investigators and CROs to ensure on-time delivery, quality, and compliant submission documents.

This role emphasizes strategic planning, stakeholder management, risk mitigation, and continuous-improvement within a matrix, cross-functional environment across multiple pathways (SRC, MAP, IITs, NIS, RCs, PLD).