Clinical Project Manager Medical Devices

Clinical Trial Project Manager Medical Devices
Our client, a global pharmaceutical organisation based in Cork are currently recruiting for a Clinical Trial Project Manager to join their newly created team on a permanent basis. As Clinical Trial Project Manager you will lead the cross-functional study team in the development and execution of clinical trials and will be responsible both regionally and globally to deliver trials with quality, on time, and within scope and budget. The ideal candidate will have familiarity with device and digital health clinical development and demonstrated understanding of global device regulations.


Responsibilities

• Use project management skills, processes and tools to develop and execute local, regional and/or global clinical trials
• Partner with other organizations to coordinate and actively participate in affiliate, site, and investigator training
• Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution, and closure, empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution
• 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, CDDA, and Third Party Organization (TPOs’s)
• Apply problem-solving skills to daily issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners).
• Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
• Manage TPO qualification process, selection, and oversight.
• Accountable for ensuring 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, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.
• 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.

• Bachelors or University degree (scientific or health-related field preferred) or an advanced degree
• Familiarity with device and digital health clinical development and demonstrated understanding of global device regulations
• 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 TPOs
• Strong leadership and networking skills
• Effective and influential communication, self-management, and organizational skills
• Proficiency in use of project management tools and techniques (e.g., Critical Chain, MS Project, MS, Excel, MS Powerpoint)