Description
We are seeking a Senior Clinical Trial Manager to join our team at IQVIA Biotech. As a Sr Clinical Trial Manager, you will play a key role in leading and working alongside clinical teams to improve patients' lives by bringing new drugs to the market faster. You will be responsible for the clinical delivery of full-service, large, multi-regional studies to meet contractual requirements and in accordance with Standard Operating Procedures (SOPs), policies, and practices.
Essential Functions:
- 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 ensuring appropriate recruitment strategies are in place.
- Contribute to the development of the project risk mitigation plan and manage clinical risks throughout 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 Finances, including Estimate at Completion (EAC).
- Work as the primary CTM alongside other CTMs to deliver large, global trials.
- 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 and report to internal and external stakeholders as per project scope requirements.
- Resource and talent planning of the clinical team, managing the clinical team at project level to successfully deliver the project.
- 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.
- Adopt corporate initiatives and changes and serve as a change advocate when necessary.
- May contribute to the development of the clinical delivery strategy for business proposals and participate in bid defense preparations and meetings.
- May mentor and coach new peers as they assimilate into this role.
Qualifications:
- Bachelor's Degree in healthcare or other scientific discipline required.
- Ideally at least 5 years of experience in clinical trial management or equivalent combination of education, training, and experience.
- Requires consolidated knowledge of Project management practices and terminology.
- Requires 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.
- Requires good understanding of the Clinical Research industry and the relevant environments in which it operates.
- Requires understanding of project finances.
- Knowledge of clinical trials, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines.