Clinical Project Lead
We are seeking an experienced clinical project lead to manage cross-functional study teams in the development and execution of clinical trials.
Responsibilities:
* 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 local, regional and global, 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 to and from the Clinical Development team.
* Apply problem-solving skills to daily issues with cross-functional study teams.
* Identify and assist in developing continuous improvement activities based on important trends.
* Manage Third Party Organisation qualification process, selection, and oversight.
* Ensure a state of inspection readiness of the Trial Master File records created, maintained, finalized, and owned by Clinical Development.
* 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:
* Bachelors or University degree (scientific or health-related field preferred) or an advanced degree.
* Clinical trial experience with a strong working knowledge of the clinical research process.
* Applied knowledge of clinical project management methodology, processes and tools.
* Demonstrated ability to work cross-culturally with global colleagues and with Third Party Organisations.
* Strong leadership and networking skills.
* Effective and influential communication, self-management, and organisational skills.
* Proficiency in use of project management tools and techniques.
* Ability to travel periodically.
This role offers the opportunity to develop your career in clinical project management and make a significant contribution to the success of our company.