Clinical Trial Manager

4 weeks ago

Newcastle, Australia Pharmiweb Full time
As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The CTM manages assigned clinical trials, leads the FSE trial teams in order to ensure high
quality execution of the trials and deliverables within all countries in the FSE. The CTM enables the Adjacent Affiliate teams to deliver clinical trials in the shortest possible time in accordance with the sponsor policies and procedures, SOP’s, local legislation and GCP requirements.

What you will be doing:

  • Overall project management of assigned clinical trials in the FSE and adjacent affiliates
  • Responsible for deliverables and high-quality execution of clinical trials in the FSE and adjacent
    affiliates
  • Leading the FSE trial teams
  • Planning, executing, coordinating tasks and communicating between relevant roles, such as FSE CTA and CRAs in adjacent affiliates and global trial management, to facilitate the progress of the trial
  • Attending all trial related meetings / TCs and ensuring knowledge sharing across the FSE trial team
  • Proactive risk identification and executing mitigation plans at the FSE level and adjacent affiliates
  • Ensuring successful start-up of clinical activities in the FSE and adjacent affiliates (all trial related documents review, CTA dossier oversight, ensure timely HA/EC submission/approval, ensure materials for site initiation / selection, e.g. preparing presentations)
  • Responsible for trial budgets (ClinCost): preparation and tracking in the FSE and adjacent affiliates
  • Execute and follow up on Recruitment and Retention plans at the FSE level and adjacent affiliates
  • Perform Visit Report review (all type of visits)
  • Conduct co-monitoring visits across the FSE
  • CTMS set-up & update at country level (for adjacent affiliates)
  • Oversight and compliance check of STMF (nD/Veeva) for assigned clinical trials in close collaboration with FSE CTA
  • Supervise clinical supplies’ processes in the FSE and adjacent affiliates, e.g. ordering, handling
    ancillary, import-export process
  • Report timely on quality issues
  • Audit readiness, audit action plans and follow up for assigned clinical trials in FSE
  • Inspection readiness and inspection action plan for assigned clinical trials in FSE


You are:

  • Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), and applicable international regulations and guidelines
  • Clinical Development process and procedures
  • Project planning experience including oversight of study deliverables, budgets, and timelines
  • Ability to apply scientific and clinical knowledge to clinical research
  • Experience anticipating and resolving problems
  • Experience writing and presenting clearly on scientific and clinical issues
  • Experience collaborating and leading cross-functional teams (team/matrix environment)
  • Knowledge of project risk management assessment and mitigation approaches
  • Proven experience of successful collaboration in multi-national environment
  • Proven decision making and problem-solving capabilities


Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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