Project Management Lead
Clinical trials are a crucial part of pharmaceutical development. As a Project Management Lead, you will be responsible for leading cross-functional study teams in the development and execution of clinical trials. This role offers a unique opportunity to work with a talented team on a global scale.
* Develop and execute local, regional and/or global clinical trials using project management skills, processes and tools.
* Partner with other organizations to coordinate affiliate, site, and investigator training.
* Drive and coordinate cross-functional study teams throughout study implementation, execution, and closure.
* Be accountable for trial/regional enrolment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET).
* Manage relationships and serve as a single point of contact and central owner for trial communication.
* Apply problem-solving skills to daily issues with cross-functional study teams.
* Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
* Manage Third Party Organization qualification process, selection, and oversight.
* Ensure a state of inspection readiness of the TMF records created, maintained, finalized, and owned by Clinical Development.
* Apply expertise and knowledge of global/regional regulations & Good Clinical Practice (GCP) and leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents.
* Combine scientific, regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.
* Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
Requirements
Education and Experience: A bachelor's or university degree in a scientific or health-related field is required. Advanced degrees are an asset. Clinical trial experience with a strong working knowledge of the clinical research process is essential.
Skills: Applied knowledge of clinical project management methodology, processes and tools, strong leadership and networking skills, effective and influential communication, self-management, and organizational skills.
Travel Requirements: Ability to travel periodically.