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Details

Clinical Trials Project Manager


Reference:SCAIXI-826857 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Trials Project Manager
Our client, a global pharma organisation are currently recruiting for a Clinical Trials Project Manager Associate to join their Clinical Development Team. As Clinical Trial Project Manager Associate you will lead the cross-functional study team in the development and execution of clinical trials and will be accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. You will leverage project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables. This is a permanent role with hybrid working.

Responsibilities

  • Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes (per change control process) as needed to meet the deliverables of the trial
  • Develop and track 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. Routinely network with appropriate business partners, on trial-level budget status and changes.
  • Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).
  • 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)
  • Partner with Regional Operations to achieve regional enrolment goals.
  • Manage relationships and serve as a single point of contact and central owner for trial communication, to and from the CPM Organization, Regional Clinical Operations, and Third Party Organization (TPOs).
  • 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.
  • Demonstrate understanding of drug development process. Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise
  • Be knowledgeable of the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams
  • Single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is current and inspection ready at all time
Requirements:
  • Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree
  • Minimum of 3 years clinical trial experience with a strong working knowledge of the clinical research process
  • Prior clinical trial site-level or affiliate experience
  • Exploratory and biopharmaceutics clinical development experience preferred
  • 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
  • Flexibility to adjust to altered priorities
  • Proficiency in use of project management tools and techniques (e.g., Critical Chain, ProChain Enterprise, MS Project, MS Excel, MS Powerpoint)
For more information please contact Sinéad Cullen on sinead.cullen@lifescience.ie or +353879500821