Senior Specialist - Medical Operations

As a Senior Specialist, Medical Operations, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Program management activities: Has responsibility supporting specific tasks/assignments with supervision and oversight:
  • Pharmacovigilance Compliance activities - IAL distribution and appropriate tracking of receipt and delivery, and/or SAE reconciliations
  • Drug Supply Management – Tracking of drug inventory per product, executing shipments and processes drug related issues, inclusive of temperature excursions, expiry events, quarantines, drug destructions and product complaints
  • Essential Document Maintenance – ensures all appropriate documentation in support of a proposal has been collected and filed correctly within the document repository systems on an ongoing basis.
  • Due Diligence process – may assist with verifying PI’s are not included in OIG exclusion list, FDA debarment list, and completing ABAC requests.
• Systems Management: Learns to use appropriate systems which contribute to cross-functional communication, planning and transparency, including but not limited to:
  • Running of reports in preparation for financial and/or study status update meetings, including QlikSense, QlikView, SharePoint, and ERRS portal (Polaris)
• Process: Adheres to all relevant processes, trainings, and SOPS to ensure consistency, efficiency, and compliance.

You are:

• 6+ years of "progressive" industry experience.
• Bachelor's degree 
• Works well in fast-paced, dynamic environment, self-motivated, works with limited supervision, once acclimated to role and enjoys working with different stakeholders.                                                                                                                                                                                                                                                                                                             

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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