Study Start Up Manager

2 weeks ago

Sydney, New South Wales, Australia Pharmiweb Full time
Job Title: Study Start Up Manager

As a Study Start Up Manager at ICON, you will be responsible for managing and performing activities at a site level associated with study start-up, including regulatory document collection, preparation of ethics submission documents, informed consent review, and essential document package review.

Key Responsibilities:
  • Build and cultivate relationships with key study personnel, including Study Coordinators
  • Work directly with Investigative Sites for all aspects of study start-up, including activation timeline development, regulatory document preparation and collection, assisting with IRB/EC submissions, and informed consent review
  • Assist in creation, review, and customization of country/site-specific Informed Consent Forms (ICFs)
  • Assist in drafting and responding to IRB queries and facilitating responses to EC queries
  • Assist in contract and budget negotiations, as necessary
  • Manage translations of relevant study documents
  • Proactively identify site challenges and implement appropriate mitigations
  • Provide regular local status updates to the study team and escalate risks to timelines
  • Manage and track issues and escalations to internal stakeholders
  • Assist in the development of start-up plans
  • Update study-tracking tools and databases with site status
  • May participate in feasibility and/or site identification activities
Requirements:
  • Bachelor's degree with a major in a related field and at least 5 years of experience in study start-up
  • In-depth knowledge of start-up processes and procedures
  • Solid understanding of key regulatory authorities and regulatory requirements
What ICON Offers:

At ICON, we value diversity, inclusion, and belonging. We are committed to providing an inclusive and accessible environment for all candidates. We offer a range of benefits, including competitive salary, annual leave entitlements, health insurance, retirement planning, and flexible country-specific optional benefits.

We are 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 through the form below.

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