Sr Global Trial Manager (Sponsor Dedicated) -POLAND
Descripción del trabajo
Job Profile Summary
Clinical lead plays 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. Member of the core project team responsible for clinical delivery of full service, large, multi-regional studies to meet contractual requirements and in accordance with (Standard Operating Procedures) SOPs, policies and practices. Clinical Lead ensure clinical delivery to customers by leading clinical teams and partnering with Project Leaders and 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). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline and identify additional service opportunities or out of scope work.
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.
Conduct regular team meetings and communicate appropriately to achieve objectives.
Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development.
May contribute to the development of the clinical delivery strategy for business proposals. Participate in bid defence preparations and meetings. 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.
Minimum of Bachelors Degree in Health Care or other Scientific Discipline
Requires 7 years clinical research/monitoring experience or equivalent combination of education, training and experience.
Requires consolidated knowledge of Project management practices and terminology.
Good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.;
Requires broad protocol knowledge and therapeutic knowledge.;
Good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
Requires understanding of project management
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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