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Research Scientist Leader
2 weeks ago
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.
- 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.
