Our company is recruiting for a Clinical Project Manager to join their clinical development team.
Responsibilities
* Develop and execute local, regional and/or global clinical trials using project management skills and processes.
* Partner with other organizations to coordinate and participate in 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 develop continuous improvement activities based on industry trends.
* Manage Third Party Organisation qualification process, selection and oversight.
* Ensure a state of inspection readiness of the Trial Master File records created, maintained, finalised and owned by Clinical Development.
* Prepare and provide technical consultation for clinical and regulatory documents, meetings with regulatory agencies and responses to questions from regulatory agencies, Third Parties and affiliates.
* Combine scientific, regional and operational knowledge to impact clinical trial design, feasibility and implementation.
Requirements
* Bachelor's or University degree in a 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 Parties.
* Strong leadership and networking skills.
* Effective and influential communication, self-management and organisational skills.
* Proficiency in use of project management tools and techniques such as Critical Chain, MS Project, Excel and Powerpoint.