Clinical Trials Application Senior Associate/Manager


Clinical Trials Application Senior Associate/Manager, Diamond BioPharm

Reports to: Regulatory Affairs Senior Manager

Based at: No No 4 East Wing, Gemini House, Flex Meadow, Harlow, Essex, CM19 5TJ, UK or Cambridge Science Park, Milton Road, Cambridge, CB4 0FN or London Stratford, E15 2ST

Job description: Diamond BioPharm Limited is a Regulatory consultancy company dedicated to providing high quality and competitively priced services to the biotech and pharmaceutical industries. The Clinical Trials Application Senior Associate/Manager will take the initiative with the organisations Clinical Trial Activities.

Key Responsibilities and duties of the role

  • Prepare and submit clinical trial applications and substantial amendments to competent authorities and ethics committees throughout Europe, with an emphasis on UK & IE submissions.
  • 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

Professional Experience

Essentials:

  • 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

Preferable:

  • Previous experience within a CRO environment

Personality attributes

  • Confident/Enthusiastic/Outgoing
  • Ability to lead a team
  • Self-motivated with excellent communication skills
  • Well organized and good planning abilities
  • Strong attention to detail
  • Multi-tasking