Clinical Study Manager

1 month ago


Canada Pharmaceutical Research Associates, Inc Full time
Job Title: Clinical Study Manager

At ICON plc, we're committed to fostering an inclusive environment that drives innovation and excellence. We're seeking a highly skilled Clinical Study Manager to join our team and contribute to our mission to shape the future of clinical development.

Key Responsibilities:
  • Lead and coordinate cross-functional study teams to ensure clinical studies progress as planned, meeting milestones, timelines, budget, and quality standards.
  • Contribute to vendor/ESP selection activities, including bid defense, and lead operational oversight to ensure control over vendor identification and selection.
  • Assist the Senior GPD with operational planning for upcoming clinical studies, establishing required resources and interfacing with cross-functional partners and the TA as needed.
  • Be the primary point of contact for the CRO Study Manager, ensuring study delivery according to agreed-upon timelines, budget, and quality standards, while maintaining oversight and documentation.
  • Develop and maintain relevant study plans, including global study management plans, study project plans, and quality and risk management planning.
  • Oversee study level performance against agreed-upon plans, milestones, and KPIs, using company tracking systems and project timelines, and communicate risks to timelines and/or quality to CPT, along with proposed mitigations.
  • Identify and report quality issues within the study, collaborating with all functions as necessary to overcome barriers and achieve milestones.
Requirements:
  • University degree (or equivalent) in medical or biological sciences or a discipline associated with clinical research.
  • Proven project management experience and training.
  • Experience in CAR-T studies is required.
  • Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements, with experience in all phases of clinical study delivery.
  • Strong abilities in establishing and maintaining effective working relationships with senior stakeholders, along with strong conflict management skills.
  • Ability to manage multiple competing priorities.
What We Offer:
  • 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.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

We're an equal opportunities employer and welcome applications from all qualified candidates. If you need a reasonable accommodation for any part of the application process, please let us know or submit a request here.



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