Global Study Start-Up Specialist

7 days ago

Dublin, Dublin City, Ireland beBeeClinicalTrial Full time €55,000 - €75,000
Job Overview

The Study Start-Up Lead is a key role in planning and executing global Study Start-Up activities. This includes ensuring timely trial document and task completion, facilitating country Health Authorities and Ethics Committee submissions, and site activation to meet ambitious recruitment plans.

Key Responsibilities:
  • Study Start-Up Leads integrate Study Start-Up insights into the trial Operational Execution Plan. This involves aligning with milestones and dashboards alongside the Study Leader.
  • They oversee trial-specific setup of Study Start-Up systems, including tasks, personnel, vendors, translations, site contracting tools, and templates. They prepare Study Start-Up planning and lead the team from kick-off through completion for global site enrollment, adhering to timelines and trial requirements.
  • Study Start-Up Leads ensure timely collection of global trial-level documents for submission and eTMF entry. This supports health authority and Ethics Committee approvals.
  • They collaborate with Vendor Program Manager and Global Clinical Supplies to ensure vendor activation, site readiness, and clinical supply alignment for site initiation.
  • Study Start-Up Leads provide proactive oversight, managing risks to ensure quality Study Start-Up execution and adherence to timelines/regulations. They implement corrective actions if required.
  • They ensure the proper use of technology platforms, completeness of data, and alignment of global budgets/processes to support Study Start-Up activities and timelines.
Essential Requirements:
  • A degree in a scientific or health discipline is required; an advanced degree with clinical trial and/or project management experience is preferred.
  • Fluent English, spoken and written, is essential.
  • Minimum 2 years overseeing and/or monitoring clinical trials, plus 1 year contributing to their planning, execution, and reporting, are necessary. Proven ability to engage and lead diverse teams in a global, matrixed environment is also required.
  • Excellent influencing, communication, and negotiation abilities at all organizational levels are necessary.
  • A strong understanding of Good Clinical Practice, clinical trial design, and global drug development processes is required.
  • Experience with electronic systems, clinical/project management analytics, and willingness to embrace new technologies are essential.
  • A data-driven mindset and dedication to meeting deadlines effectively are necessary qualities.

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