Senior Global Trial Managers (SGTMs) are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The SGTM is a member of the core project team responsible for clinical delivery of large, multi-regional studies to meet contractual requirements and in accordance with (Standard Operating Procedures) SOPs, policies and practices. SGTMs ensure clinical delivery to customers by leading clinical teams and partnering with other functional teams to ensure projects meet delivery requirements at all times.
Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
Accountable for meeting projects’ Clinical targets
Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle.
Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
Manage clinical aspects of Project). Monitor and manage changes against Study work plan (SWP) and identify additional service opportunities or out of scope work to be manage on a Change in Scope (CIS) process.
Work as the primary Point of contact for the customer project manager
Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development.
Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
May attend site visits as applicable in support of project delivery.
Bachelor’s degree in health care or other scientific discipline required.
Requires 7 years clinical research/monitoring experience or equivalent combination of education, training and experience.
Requires consolidated knowledge and understanding of Project management practices and terminology.
Requires good knowledge of applicable clinical research regulatory requirements i.e., Requires understanding of project finances to oversee the clinical/monitoring budget and changes to scope.
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. 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.