Lead Clinical Project Manager

7 days ago

Guelph, Ontario, Canada ICON Strategic Solutions Full time
Company Overview

At ICON Strategic Solutions, we're a leading clinical research organization that's dedicated to bringing life-changing treatments to patients worldwide.

We're a dynamic team of experts who are passionate about delivering exceptional results and making a meaningful impact on people's lives.

About the Role

We're currently seeking a highly skilled Lead Clinical Project Manager to join our team. As a key member of our global trials team, you'll play a critical role in ensuring the successful execution of our clinical trials.

As a Senior Global Clinical Project Manager, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

  • Joining a well-established yet expanding team fully outsourced to one of our global pharmaceutical clients, the Clinical Trial Manager ensures overall successful execution of phase 1-4 clinical trials in multiple therapeutic areas, in accordance with applicable Standard Operating Procedures, agreed timelines, budgetary and regulatory requirements, at a global scale.

The Clinical Trial Manager serves as the leader for the Study Management Team, with ultimate responsibility for the set-up, planning and coordination of clinical trials through to study closure. Managing and tracking key study metrics to ensure adherence to project milestones, along with communicating with other departments, will form a key part of this role.

Reporting to a Clinical Program Leader, you will ensure accurate budget management, including guaranteeing that third-party vendors are working to defined plans.

Other fundamental tasks include driving activity to ensure that enrolment commitments are met, whilst also checking that relevant documentation is duly updated, resolving problems, proactively managing risk and (where necessary) timely escalating issues. Clearly, the Clinical Trial Manager will also work in accordance with applicable health authority regulations and internal standard operating procedures. Where necessary, participation in the preparation for and conduct of Health Authority inspections and internal audits will also feature in this role.

Responsibilities
  • Deliver appropriate training to your study team on a trial-specific basis.
  • Act as a key liaison with Quality Management in order to establish a high level of quality throughout the project lifecycle.
  • Ensure the successful execution of clinical trials from start-up to database lock and trial closure.
  • Manage and track key study metrics to ensure adherence to project milestones.
  • Communicate effectively with other departments to ensure seamless project execution.
Requirements

To qualify for this role, you should have:

  • A BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).
  • Previous experience of working with multiple therapeutic areas, including oncology, cardiology, infectious disease, immunology, vaccines is preferred.
  • 6 - 8 years clinical trial management/trial oversight experience in the pharmaceutical industry or CRO.
  • A proven track record in successfully managing various aspects of trials from Start-Up to Database Lock and Trial Closure (End to End study experience).
  • Experience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness.
  • Approximately 15% – investigator meetings (this could include international travel), face to face training, vendor visits, quarterly team meetings face to face.
  • To qualify, applicants must be legally authorized to work in the United States and/or Canada, and should not require, now or in the future, sponsorship for employment visa status.
What We Offer

We're proud to offer a range of benefits to support your career development and well-being, including:

  • Various annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximise 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 specialised 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, subsidised travel passes, health assessments, among others.

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