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
- 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
- Previous experience within a CRO environment
- Ability to lead a team
- Self-motivated with excellent communication skills
- Well organized and good planning abilities
- Strong attention to detail