*clinical lead*
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.
the cl is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with standard operating procedures (sops), policies and practices.
*you will*:
- 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 throughout 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.
- identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
*what do you need to have?*
- advanced degree or equivalent education/degree in life science/healthcare recommended.
- 7 years clinical research/monitoring experience; or equivalent combination of education, training and experience.
- * at least 2-3 years leading clinical research studies (regional and/or globally speaking)*. Involvement in cross-functional, multicultural and international clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities.
- fluent english (oral and written).