- BSc or equivalent in biomedical, health of life science field
- Proven clinical trial experience, clinical trial management; CRO experience preferred.
- Experience in Phase I-IV trials; Phase II - III is preferred.
- 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
- Working knowledge of BS EN ISO 14155
- Strong, professional leadership experience
- Design clinical and application research studies.
- Author Clinical Investigation Plans (CIP) and Final Study Reports (FSR)
- Statistically analyse clinical data
- Draft clinical manuscripts for publication
- 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.
- Maintain up-to-date knowledge of relevant industry guidelines.
- Oversee activity of trial sites
- Contribute to all trial management activities including budgeting.
- Develop operational project plans.
- Manage trial associates, investigators, and other trial personnel to ensure personnel are up to date with relevant information or issues. Delegate workloads accordingly.
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Clinical Trials Manager - Swansea, United Kingdom - The Recruitment Co.
Description
The Recruitment Co are recruiting for an experienced Clinical Trials Manager to join our clients expanding team. A world-leading manufacturer of high-quality technical products.
Contract: Permanent
Salary: £45,000pa
Shifts: Full time
The Role: Responsible for all aspects of clinical trial management. The post holder will have a significant level of responsibility. 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. You will also be responsible for ensuring trials are delivered on time and within budget constraints.
You will coordinate the work of the clinical and application research team across two sites, ensuring work scope and training needs are met; to inspire, motivate and increase employee productivity. Ensuring the department maintains its high quality, auditable system for the standardisation of trial conduct in accordance with all regulatory standards.
Essential Requirements:
Key Objectives/KPI's
If you have the required skills and experience required for this role then please submit your CV for immediate response.
CPSwansea
The Recruitment Co. is an equal opportunities employer and we're committed to diversity and inclusion in the workplace.
