Lead Clinical Trial Manager
Our pharmaceutical organization is seeking a Lead Clinical Trial Manager to join their clinical development team. The successful candidate will lead cross-functional study teams in the development and execution of clinical trials, ensuring quality, timely delivery, and compliance with regulatory requirements.
* Develop and execute local, regional, and global clinical trials using project management skills, processes, and tools.
* Partner with other organizations to coordinate and participate in affiliate, site, and investigator training.
* Drive and coordinate cross-functional study teams throughout study implementation, execution, and closure, empowering them to meet clinical trial deliverables.
* 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 for trial communication to and from the Clinical Development team and Third Party Organizations.
* Apply problem-solving skills to daily issues with cross-functional study teams, including vendors, affiliates/regions, global team members, and business partners.
* Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, and new technology.
* Manage TPO qualification process, selection, and oversight.
* Ensure a state of inspection readiness of TMF records created, maintained, finalized, and owned by Clinical Development.
* Apply expertise and knowledge of global/regional regulations and Good Clinical Practice (GCP) and leverage scientific and regulatory knowledge to prepare technical consultation for clinical and regulatory documents.
* Combine scientific, regional, and operational knowledge 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.
Required Skills:
* 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 Organizations.
* Strong leadership and networking skills.
* Effective and influential communication, self-management, and organizational skills.
* Proficiency in use of project management tools and techniques.
This role offers hybrid working arrangements. For more information, please contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie