Site Start-Up Expert

24 hours ago

Sydney, New South Wales, Australia beBeeStudy Full time $90,000 - $120,000
Job Overview

We are seeking an experienced professional to join our team as a Study Start-Up Specialist. This role is responsible for country site start-up activities, ensuring timely and high-quality delivery while mitigating risks.

Main Responsibilities:
  • Deliver site activation within assigned countries/sites, guaranteeing timeliness and quality.
  • Prepare and support EC/IRB submissions, collect and review regulatory documents, notify IRB, EC, and regulatory authorities as required.
  • Develop start-up plans and essential document checklists.
  • Partner with assigned site CRA to ensure alignment in communication and secure site collaboration.
  • Review and manage collection of essential documents required for site activation/IMP release.
  • Customize country/site-specific Patient Information Sheet and Informed Consent Forms.
  • Maintain communication with key functions participating in country start-up, including Clinical Operations, Project Management, Regulatory, and Site Contracts management group.
  • Act as SME for collection and maintenance of local IRB/Ethics Committee (EC), other related organizations, site contracts, and budget negotiations.
  • Support feasibility group in site outreach to assess potential interest of investigators in a potential study.
  • Develop country-specific Country Start-up summary and process flow, identifying timelines, risks, and success factors.
Requirements:
  • Bachelor's degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience.
  • 5 years or more as a SSU specialist in a CRO or pharmaceutical/biotech industry or equivalent, relevant experience, and/or demonstrated competencies.
Preferred Skills:
  • Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country.
  • Experience using Study Start-up tracking tools/systems.
  • Ability to prioritize workload to meet deadlines.
  • Ability to assist junior SSU activate specialists in problem resolution.
Key Competencies:
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Ability to follow task-specific procedures, be attentive to detail, and place importance on accuracy of information.
  • Strong organizational skills.
  • Ability to effectively interact with project teams and communicate in English and the local language of the country where located.
  • Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.
  • Excellent computer skills.
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
About this Role

This is an excellent opportunity to join a dynamic team and take on a challenging role that requires strong analytical and problem-solving skills. If you have a passion for delivering high-quality results and making a real difference, we encourage you to apply for this position.

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