On behalf of my client, a global pharmaceutical company, we have a new vacancy for a Clinical Quality Manager (GCP) to join the team in Dublin. This is a newly created role with hybrid offering.
Clinical Quality Manager (GCP)
To be successful, note the following essential requirements:
- We require a person with GCP experience related to clinical trials from the Sponsor perspective.
- You will have a robust knowledge and practical understanding of GCP regulations.
- Experience in setting up processes in a leading role and not supporting role.
- A good understanding of pharma stakeholder landscape when it comes to sponsored clinical trials.
- Demonstrated knowledge of ICH GCP, global regulations and guidelines applicable for the conduct of clinical trials.
Your role:
You will be responsible to ensure compliance with SOPs, GxP, European regulations, local regulations and guidelines, and clinical study protocols. This position will collaborate with other global functions such as Clinical Operations, Medical, Regulatory, Project Management, Pharmacovigilance etc.
Responsibilities:
- Establish appropriate system for clinical quality management and oversight a of investigational sites and vendors.
- Collaborate with stakeholders in the cross functional departments (Clinical Operations, Project Management Office, Medical, Regulatory, PV etc.) to support clinical trial programs for the organisation for both new compounds and new indications for marketed products.
- Maintain GCP/ICH compliant systems and processes which control the quality of work and clinical trials conducted globally and locally, where required
- Support in writing clinical documented process in applicable SOPs and support continuous process improvements.
- Ensure processes compliance to applicable Standard Operating Procedures (SOPs) and regulations.
- Manage inspection readiness and coordinate its activities.
- Qualify CRO and other vendors related to the clinical activities.
- Create risk-based study-specific audit plans, schedule, and conduct investigator site audits per the study audit plan to ensure study conduct at the audited site complies with applicable Regulations and Good Clinical Practice standards.
Requirements:
· University degree (preferably Life Science).
· Strong communication skills both written and verbal.
Fantastic opportunity to join a fast growing organisation with exciting portfolio pipeline.
FULL SPEC ON REQUEST
· For full details email your CV to [email protected] or call Tina at +353 1 2784701 / 087 6811990. Thornshaw Scientific is a division of the CPL Group. www.thornshaw.com
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