Senior Global Clinical Trial Manager

2 weeks ago

Canada, CA ICON Strategic Solutions Full time

ICON is looking for a Senior Global Clinical Project Manager, with at least 7 years of relevant clinical experience at a CRO, Pharmaceutical or Biotech Company and at least 2 years full scope global management experience. Running Oncology Trials is required.



Typical Accountabilities:

  • Lead and coordinate a cross-functional study team of experts to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards;
  • Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan;
  • For outsourced studies, be the primary point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study;
  • Provide input and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR));
  • Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented;
  • Develop and maintain relevant study plans including required input into study level quality and risk management planning ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team;
  • Oversee study level performance against agreed upon plans, milestones and key performance indicators by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations;



Requirements:

  • Senior Global Clinical Project Manager, with at least 7 years of relevant clinical experience at a CRO, Pharmaceutical or Biotech Company and at least 2 years full scope global management experience. Running Oncology Trials is required.
  • Deep understanding of clinical operations and study management processes, along with experience with the clinical/drug development process in various phases of development and therapy areas;
  • Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development;
  • Strong abilities in cross-functional team leadership, driving personal and team accountabilities, working collaboratively, critical thinking, decision-making, and influencing;
  • Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and stakeholders, along with strong conflict management skills.
  • University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred;
  • Oncology experience required
  • January start date

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