ICON

Site Activation Manager - UK - client-dedicated

Company
ICON
Location
Home based in United Kingdom
Salary
Salary dependent on experience
Posted
27 Aug 2021
Closes
26 Sep 2021
Ref
FC 2021 79655
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Working directly with Investigative Sites, this role will independently manage and perform 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. Reporting to the Site Activation Strategist, the Start Up Manager must have an in-depth understanding of study start-up activities and associated regulatory requirements.

Key Responsibilities 

  • Build, cultivate and manage 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, IRB/EC submissions and informed consent review
  • Draft and respond to IRB queries and facilitate responses to EC queries
  • Create, review and customization of country/site specific Informed Consent Forms (ICFs)
  • Negotiate site contracts and budgets, as necessary
  • Manage translations of relevant study documents
  • Manage the Clinical Research Organization/Functional Service Provider for outsourced tasks
  • Provide regular local status updates to study team
  • Manage and track issues and escalations to internal stakeholders
  • Develop start-up plans and oversee the execution of plans for assigned sites.
  • Update study-tracking tools and databases with site status
  • Proactively identify site challenges and implement appropriate mitigations
  • Resolve and escalate site issues as appropriate
  • Manage feasibility and/or site identification activities for assigned sites
  • Work directly with key internal client personnel to share information, manage and triage issues

Minimum Qualification

  • Bachelor’s degree with a major in a related field and experience in study start-up In-depth knowledge of start-up processes and procedures
  • Must have good working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines
  • Experience with investigative site start-up documents
  • Good understanding of clinical trial execution
  • Fluency in English

Key Competencies Required

  • Ability to work under pressure to meet deadlines
  • Self-motivated and ability to work well independently and in a team environment
  • Ability to effectively manage multiple priorities
  • Excellent verbal and written communication
  • Excellent project management skills
  • Excellent collaboration skills
  • Meticulous attention to detail and process oriented

ICON 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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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