Ensure the execution of clinical trials for assigned projects in accordance with regulatory requirements (International Council for Harmonisation (ICH)
Good Clinical Practice (GCP), protocol), client requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
Ensure project enrollment targets are met and implement appropriate recruitment strategies.
Contribute to the development of the project risk management plan and manage clinical risks throughout the project lifecycle.
Ensure the quality of clinical trials by identifying quality standards and requirements, planning compliance assessment activities, and tracking and managing clinical quality issues.
Manage clinical aspects of project financials, including Estimate at Completion (EAC). Understand the scope of clinical deliverables and develop plans for their implementation. Monitor and manage variances relative to the baseline EAC and identify opportunities for additional services or out-of-scope work.
Identify project clinical stakeholders and manage internal and external stakeholders through effective communication and rigorous issue management.
Collaborate with the clinical team to achieve objectives. Report to internal and external stakeholders in accordance with project requirements.
Plan clinical team resources and talent.

Bachelor’s degree in health sciences or other scientific discipline required.
5 years of experience in clinical research/monitoring or an equivalent combination of education and experience required.
Basic knowledge of project management practices and terminology required.
Strong knowledge of regulatory requirements applicable to clinical research, including Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
Solid knowledge of protocols and therapeutic areas.
Understanding of project financial aspects.

Senior Clinical Trial Manager, IQVIA Biotech

Key skills