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Clinical Research Manager
2 semanas atrás
Job Overview
Clinical Research Managers play a pivotal role in the delivery of clinical trials, collaborating with cross-functional teams to accelerate the development and commercialization of innovative medical treatments. As a Clinical Lead, you will be part of the core project team responsible for the clinical delivery of studies, ensuring timely completion in accordance with contractual requirements, Standard Operating Procedures (SOPs), policies, and practices.
Key Responsibilities:
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer requirements (contract), and internal requirements (policies, SOPs, project plans).
- Accountable for meeting projects' recruitment targets and implementing effective recruitment strategies.
- Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project lifecycle.
- Guarantee clinical quality delivery by identifying quality standards/requirements, planning compliance measurement, monitoring, and overseeing management of clinical quality issues.
- Manage clinical aspects of Project Finances, including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out-of-scope work.
- Identify clinical stakeholder landscapes for the project and effectively communicate with internal and external stakeholders through resolution management.
- Collaborate with the clinical team to support milestone achievements and report to internal and external stakeholders as per project scope requirements.
- Resourcing and Talent Planning of the clinical team. Manage the clinical team at the project level to successfully deliver the project through high-quality operational plans and project-related trainings.
- Conduct regular team meetings and maintain open communication to achieve objectives.
- Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
- Mentor and coach new peers as they assimilate into this role.
- Participate in bid defense preparations and meetings. Develop and present Clinical Operation plans in partnership with Business Development and Project Leadership.
Qualifications
- Bachelor's Degree in a health care or scientific discipline required.
- 5 years of clinical research/monitoring experience or an equivalent combination of education, training, and experience.
- Basic knowledge of Project Management practices and terminology.
- Good knowledge of applicable clinical research regulatory requirements (GCP, ICH guidelines).
- Broad protocol knowledge and therapeutic knowledge.
- Understanding of Clinical Research industry and relevant environments.
- Understanding of project finances.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We strive to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide.
