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Clinical Trials Manager - Swansea, United Kingdom - Cyden Ltd
Description
Overall job purpose:
1.Creating and disseminating relevant trial documentation or document templates
2.Primary point of contact for trial specific issues and trial deliverables
3.Lead data management activities.
Background:
We are looking 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. 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.
You will ensure the department maintains its high quality, auditable system for the standardization of trial conduct in accordance with all regulatory standards.
Key Objectives/KPI's
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.
Skills, know-how & experience:
Essential Attributes
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
Other Attributes
Excellent Planning Skills. You can manage your role, and those within your team.
Proactive Attitude. You take the lead and are a forward thinker.
Data Driven. Results driven and can leverage data and business insights to identify key opportunities and potential problem areas,
Agility. You work with urgency, analysing and adapting to different situations, quickly understanding changes, and reacting confidently and decisively. You embrace an agile mindset.
Excellent Communication Skills. An inspiring communicator. You communicate clearly and concisely.
Diligent. Attentive and assiduous. Thoroughly investigate and verify issues.
Excellent Writing Skills. Expertise in technical and academic writing. You can communicate effectively and succinctly
In return we offer competitive rates of pay, 25 days holiday plus Bank holidays rising to 28 with length of service, 5% Company pension contributions, Company sick pay, career development opportunities, Employee Assistance Programme and Cycle to Work Scheme.
CyDen is committed to being an equal opportunities employer and values diversity.
