Clinical Trials Manager

2 weeks ago

Cork, Cork, Ireland beBeeTransparency Full time €45,000 - €80,000
Job Summary:We are seeking a highly skilled Clinical Trial Registry Specialist to join our team. This is an exciting opportunity to work in a dynamic environment where you will be responsible for collecting and preparing redacted documents/packages required to be submitted to various global disclosure and transparency regulations.The ideal candidate will have strong interpersonal skills, flexibility across environments and time zones, and high-level end-user computer skills. They will also have excellent written and oral communication skills in English and be able to manage multiple projects concurrently, deliver high-quality results under pressure.Key Responsibilities:
  • Develop knowledge and understanding of the redaction process
  • Collaborate cross-functionally with applicable team members and departments to obtain and review documents needed for submission
  • Collect documents that will be submitted to various global regulations by searching Veeva Vault and other document repositories
  • Upload documents in Veeva Vault in preparation for CCI and PI review and assign tasks
  • Redact documents for personal information and company confidential information based on inputs
  • Manage EMA Policy 0070, Health Canada PRCI and EU CTR workflows in Veeva Vault
  • Identify opportunities for redaction process improvement
Requirements:
  • Certificate/Diploma equivalent required
  • Strong interpersonal skills and flexibility across environments and time zones
  • Demonstrated high-level end-user computer skills (MS Office: Word, Excel, PowerPoint, etc.)
  • Strong written and oral communication skills in English
Benefits:
  • A competitive compensation package
  • A comprehensive benefits program
  • Opportunities for professional growth and development
What We Offer:
  • A dynamic and supportive work environment
  • Collaborative and innovative culture
  • Professional development opportunities

We are committed to diversity, equity, and inclusion and strive to create an inclusive workplace culture where everyone feels valued and respected.

Purpose:
Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent, transparent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.

Minimum Qualifications:
  • Certificate/Diploma equivalent required
  • Strong interpersonal skills and flexibility across environments and time zones
  • Demonstrated high-level end-user computer skills (MS Office: Word, Excel, PowerPoint, etc.)
  • Strong written and oral communication skills in English
Information/Additional Preferences:
Bachelor's degree preferred
Background in clinical Data Disclosure & Transparency and Redaction
Ability to be flexible in varying environments and with multiple customer groups
Ability to work well across cultures and time zones
Highly organized with ability to manage multiple projects concurrently, deliver high quality results
Attention to detail and commitment to excellence
Ability to work under pressure, maintain a positive attitude
Ability to work independently and collaboratively in a team
Project management experience
Willingness to travel as required

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