Description
Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster.
This is a local trial management support position, responsible for clinical delivery in Argentina.
Essential Functions
- 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’ recruitment targets and ensuring appropriate recruitment strategies are in place.
- Contribute to the development of the project risk mitigation plan and manage clinical risks through the project’s 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).
- 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.
- Resourcing and Talent Planning of the clinical team.
- 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.
Qualifications
- Bachelor's Degree in health care or other scientific discipline required.
- Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience.
- Fluency in the local country language (spoken and written) and advanced English is required.
- Based in Buenos Aires, Argentina.
- Requires basic 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.