LOCATION: CORK, IRELAND (funded relocation)
Stamp 4 or EU/UK Passport required ResponsibilitiesUse project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials.Understand the scope of work required to complete the clinical trial successfully.
Monitor the status and make changes as needed to meet the deliverables of the trial.Develop and track a global trial enrolment plan by gaining alignment and integrating inputs across functions and geographies.Assess, identify and monitor trial-level risks.Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan.Understand the cross-functional trial-level budget components.Create and monitor the overall budget and assumptions using financial tracking tools.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.ExpertiseDemonstrate understanding of the drug development process.Be knowledgeable of the global and regional operating model.Accountable for ensuring a state of inspection readiness of the TMF records created, maintained, finalized, and owned by Clinical Development.Network and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown, assess situations, and propose proactive approaches that reduce and/or mitigate risks that impact the ability to deliver the clinical trial.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.Basic QualificationsBachelors or University degree (scientific or health-related field ideally) or an advanced degree.Clinical trial experience with a strong working knowledge of the clinical research process.Applied knowledge of project management methodology, processes, and tools.Demonstrated ability to work cross-culturally with global colleagues and with TPOs.Ability to influence without authority.Strong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projects.Effective and influential communication, self-management, and organizational skills.Demonstrated ability to manage complex situations through problem-solving, critical thinking, and navigating ambiguity.Proficiency in use of project management tools and techniques (Critical Chain, MS Project, MS Excel, MS PowerPoint).Ability to travel periodically.Fluency in English and Spanish.Job TypesFull-time, Permanent
Salary35,000.00€ - 55,000.00€ per year
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