Our client is a leading Pharmaceutical company based in W.London
Main Responsibilities and Duties:
- Prepare and submit clinical trial applications and substantial amendments to competent authorities and ethics committees throughout Europe.
- Preparation of submissions using IRAS and EudraCT systems
- Review and extract information from clinical trial associated documentation (incl. IMPD’s, IB’s, EudraCT, Protocols & labelling)
- Quality Control check junior member of staff work, correct where necessary & provide feedback.
- Write, review and implement SOPs/processes
- Be responsible for Clinical Trial Management Plans & interaction with clients for CTA related activities.
- Client Facing with strong communication skills, willing to travel if required
Qualifications and Skills
- 2:1 (or above) graduate in relevant scientific discipline
- 4+ years broad Clinical Trials Experience, covering competent authority and ethics submissions
- Experience with IRAS system and HRA process for UK submissions
- Strong understanding of the regulatory environment for Clinical Trial Applications
- Ability to work under pressure and achieve timely submission and regulatory approvals
- Good computer skills