Clinical Development Professional

1 day ago

Cork, Cork, Ireland beBeeClinical Full time
Job Title

We are seeking a highly motivated and experienced Trial Capabilities Associate to join our team. As a key member of our clinical trial operations, you will be responsible for providing clinical trial capabilities in support of clinical development.

Key Responsibilities:
  • Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site's ERB and Competent Authority (CA), communicate and negotiate budgets with site personnel and internal teams, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities
  • Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
  • Identify, communicate, and resolve issues
  • Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
  • Leverage previous site / review board engagements to efficiently drive new work
  • Populate internal systems to ensure accuracy of trial / site performance
  • Understand and comply with procurements, legal and financial requirements and procedures
  • Populate Trial Master Files and libraries for future reference
  • Provide feedback and shared learning for continuous improvement
  • Leverage trial prioritization
  • Anticipate and monitor dynamically changing priorities
Qualifications:
  • Bachelor's degree preferably in a scientific or health related field
  • Understanding of the overall clinical development paradigm and the importance of efficient site activation
  • Applied knowledge of project management processes and skills
  • Appreciation of / experience in compliance-driven environment
  • Effective communication, negotiation, and problem solving skills
  • Self-management and organizational skills
  • Language Capabilities: Fluency in English and Spanish.
Other Information:
  • Two years clinical research experience or relevant experience preferred
Benefits:

We offer a comprehensive benefits package, including flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.

Diversity and Inclusion:

We are committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender.

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