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Global Study Director-CAR-T

1 month ago

Canada PRA HEALTH SCIENCES Full time
Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Responsibilities

What you will be doing:

  • Lead and coordinate a cross-functional study team of experts in accordance with SDO/STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget, and quality standards.
  • Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level to ensure appropriate control over the vendor identification and selection.
  • Assist the (Sr)GPD with the operational planning for upcoming clinical studies to establish the required number of resources for study conduct, interfacing with other cross-functional partners and the TA as required.
  • Collaborate with other functions to establish strategies and identify synergies aimed at increasing the efficiency of global study teams (core and extended).
  • Lead and facilitate communication across functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plans.
  • For outsourced studies, be the primary point of contact for the CRO Study 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, in accordance with relevant SOPs and guidelines.
  • Provide operational expertise into 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 (i.e., central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities.
  • Develop and maintain relevant study plans (e.g., global study management plan and its relevant components such as study project plan SPP), including required input into study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, etc.), 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 (KPIs, quality, and operational) 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.
  • Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g., CPT, quality assurance staff, functional line management, etc.).
Qualifications

What you will need:

  • University degree (or equivalent), preferably in medical or biological sciences or a discipline associated with clinical research.
  • Proven project management experience and training.
  • At least 7 years of clinical trial experience.
  • At least 3 years of experience in global study leadership and team leadership.
  • Experience in CAR-T studies is required.
  • Experience in Respiratory or Immunology indications preferred but not required.
  • Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery; startup, maintenance, and close out.
  • Thorough understanding of the cross-functional clinical trial process e.g., Data flow.
  • Strong strategic and critical thinking abilities.
  • Proven skillset and abilities in complex problem solving and decision-making.
  • Strong abilities in establishing and maintaining effective working relationships with senior stakeholders, along with strong conflict management skills.
  • Demonstrated abilities in mentoring.
  • Excellent communication and interpersonal skills.
  • Ability to manage multiple competing priorities.

Experience in external provider oversight and management.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements.
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers website to read more about the benefits of working at ICON.

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 or submit a request here.

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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