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Study Start Up Manager

1 month ago

Aalborg, Ålborg Kommune, Denmark Pharmiweb Full time
Job Summary

We are seeking a highly skilled and experienced Study Start Up Manager to join our team. As a Study Start Up Manager, 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 We Offer

We offer a competitive salary and a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a global Employee Assistance Programme.