Senior Manager Clinical Inspection Readiness
Location: London or Ireland based – 3 days on site
Contract: 12 months
Rate: Competitive daily rate plus benefits
Travel: Travel to study sites may be required to assist with monitoring clinical studies.
Cpl Life Sciences have partnered with a global, well respected Biotechnology company to bring on board a Senior Manager. This role will provide inspection readiness leadership to internally sourced studies and studies outsourced to Clinical Research Organisations (CROs) and serves as the key CTM inspection readiness point person for internal/external team members.
Essential requirements:
- BSc degree in a relevant subject
- Global agency inspection experience
- Strong industry experience
- Trial management system experience
- Extensive knowledge in research & development with experience in global clinical trial operations
- Able to develop protocols and key study documents
- Quality focused with effective project management skills, and cross-functional team leadership skills
Key Responsibilities are but not limited to:
- Key point of contact for CTM inspection readiness activities and for internal and external colleagues.
- Work with Clinical Study Team and other areas to support CTM in providing responses to sessions held by Inspection Management for Inspection Readiness
- Support ongoing CTM activities related to TMF health and oversight
- Provide guidance on compliance and regulations
- Ensure CTM staff study teams are following targeted SOPs during study,
- Track inspection readiness meetings, CTM Inspection action items etc with key stakeholders (internal/CRO) until close out
- Support the CTM processes related to Inspection Readiness to ensure that appropriate documentation is produced/maintained in the TMF,
- Work with the Clinical Study Leads, CRO and/or Vendor team(s) to obtain all the necessary essential and regulatory documents for all study/sites
- Track CTM action items assigned following inspections to ensure action plans are in place for remediation, as needed, with timelines for completion.
If this roles sounds of interest please apply direct, send your CV to