Clinical Research Manager - Medical Devices, FDA Submissions

HIRANI; Belfast City District; Hybrid; GBP 65.000 - 95.000; Vollzeit

Benefits dieser Stelle

Private Health Insurance

Zusammenfassung

Neurovalens is seeking an experienced Clinical Research Manager to lead the planning, execution and oversight of our clinical trials and regulatory submissions for medical devices. Based in Belfast, you will manage timelines, budgets and stakeholder communications, and collaborate with global investigators, CROs and internal teams.

The role requires a Life Science degree, at least five years in clinical research, strong regulatory knowledge, and excellent communication and organisation skills.

Qualifikationen

• Degree in Life Science or related field.
• At least five years of clinical research experience.
• Experience in statistical analysis of clinical trial data.
• Familiarity with QMS in regulatory environment.
• Regulatory knowledge of medical devices.
• Excellent written and verbal communication skills.
• Demonstrates prioritisation and teamwork.
• Excellent organisation skills and ability to meet deadlines.
• Proficient with Microsoft Word, Excel and PowerPoint.
• Potential for share options and private health insurance.

Aufgaben

• Lead the management and coordination of clinical trial sites.
• Develop and maintain relationships with investigators and study staff.
• Lead investigator meetings and other study-related meetings.
• Prepare and manage clinical binder content.
• Prepare ethics submissions.
• Ensure studies follow the protocol, SOPs and GCP.
• Establish clinical timelines and performance metrics.
• Arrange CDA/Budget and other trial setup agreements.
• Negotiate and manage contracts, budgets, and payments for CROs.
• Compile study KPI and performance metrics and deliver trial data.
• Perform statistical analysis of trial outcomes.
• Prepare materials for FDA submission and regulatory bodies.
• Maintain regulatory compliance and conduct background research.

Kenntnisse

Clinical research experience

Statistical analysis

Regulatory knowledge

Communication skills

Organization

Teamwork

MS Office

Ausbildung

Degree in Life Science

Jobbeschreibung

Neurovalens is seeking an experienced Clinical Research Manager to lead the planning, execution and oversight of our clinical trials and regulatory submissions for medical devices. Based in Belfast, you will manage timelines, budgets and stakeholder communications, and collaborate with global investigators, CROs and internal teams.

The role requires a Life Science degree, at least five years in clinical research, strong regulatory knowledge, and excellent communication and organisation skills.