- Design clinical and application research studies.
- Author Clinical Investigation Plans (CIP) and Final Study Reports (FSR)
- Statistically analyse clinical data
- Prepare abstracts, power-point presentations and posters for submission to scientific conferences.
- Understand how clinical data can best assist product launch/sales.
- Conduct audits and trend /gap analysis on key elements of trial execution.
- Assume PI responsibility for all clinical trials.
- Develop operational project plans.
- Requirements of the Clinical Trials Manager:
- BSc or equivalent in biomedical, health of life science field.
- Proven clinical trial experience, clinical trial management; Working knowledge of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR and Research Governance Framework Legislation with proven ability to apply these to the coordination of clinical trials.
- Understanding of current EU Medical Device Regulation.
- Evidence of preparing regulatory and ethics submissions, writing/amending Clinical Investigation Plans, Patient Information Forms and electronic Case Report Forms, plus other relevant trial management documentation.
- Attractive starting salary between £45,000
- Permanent Contract with career progression
- Excellent company package including workplace pension, life assurance, product discounts and healthcare plan.
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Clinical Trial Manager - Swansea, United Kingdom - Smart Workforce Solutions
Description
We are seeking for an enthusiastic experienced Clinical Trials Manager to join our Clinical and Application Research department. You will be responsible for all aspects of clinical trial management.Duties will include designing plus authoring trial documentation and regulatory submissions, plus monitoring the progress and performance of multiple trials from participant identification and recruitment through to ensuring reliable data collection.
This will be achieved through implementing/modifying established department procedures to ensure studies are conducted in accordance with contractual agreements, protocol, SOPs, regulatory and ethical requirements including ICH-GCP guidelines.
Key Responsibilities of the Clinical Trials Manager:
