Clinical Affairs Specialist
Position Summary
We are seeking a passionate and experienced self-employed/freelance Clinical Affairs Specialist in the Medical Device Industry. In this role, you will be involved in designing, planning, implementing, and managing clinical research projects to ensure compliance with protocols, SOPs, and regulations. This position requires an enthusiastic self-starter who is eager to contribute hands-on and possesses excellent organizational and multi-tasking skills. The ability to work in a flexible and entrepreneurial environment is essential.
Key Responsibilities
Clinical Study Management: Assist interdisciplinary team members in planning, executing, and closing both pre-market and post-market clinical studies.
Document Development: Develop and approve study-specific documents, tools, presentations, and processes.
Ethics Submissions: Prepare ethics submissions and study-specific documents such as protocols, patient information leaflets, informed consent forms, and case report forms.
File Maintenance: Maintain Trial Master Files and Investigator Site Files for multiple studies.
Investigator Meetings: Prepare and present at Investigator meetings.
Site Qualification: Participate in site qualification, study initiation, and study closure processes.
Device Tracking: Assist with the management of medical device tracking and accountability.
Database Management: Create and maintain study databases, including data entry and routine data/CRF reviews to ensure data integrity, accuracy, and protocol compliance.
Progress Tracking: Track and report study progress to internal stakeholders, including patient screening, enrollment, data collection, adverse event documentation, and reporting.
Study Reports: Develop study reports and provide clinical reports for regulatory submissions.
Monitoring and Site Visits: Perform monitoring and site visits, including preparation of site visit, data query, adverse event, and study deviation reports.
Liaison Role: Act as a company liaison with clinical sites, Contract Research Organizations (CROs), Site Management Organizations (SMOs), and other vendors/consultants.
Regulatory Compliance: Maintain familiarity with all applicable regulatory requirements and relevant clinical literature.
Regulatory Standards: Ensure compliance with ISO 13485, ISO 14155, ICH GCP, EU MDR, US 21 CFR 820, Declaration of Helsinki, Data Protection Act, and other clinical study/trial regulations.
Additional Duties: Carry out other clinical-related duties and activities related to QMS documentation control as required.
Essential Skills and Qualifications
Minimum of 4 years of experience in the Medical Device industry.
Essential:
Educational Background: Bachelor's degree in Science or related disciplines.
Clinical Study Experience: Essential experience in pre-market and post-market clinical studies of medical devices.
Regulatory Knowledge: Thorough understanding of ISO 13485, ISO 14155, ICH GCP, US 21 CFR 820, and EU MDR.
Proven track record of successfully managing projects to deadlines.
Strong ability to manage critical projects as part of an interdisciplinary team.
Excellent problem-solving and communication skills.
Highly organized and detail-oriented.
Excellent oral and written communication skills.
Ability to work effectively as part of a cross-functional team.
Thrives in a fast-paced, entrepreneurial environment.
Desirable Skills and Qualifications
Certifications: Clinical certifications are desirable.
Advanced Education: Master's degree in a relevant field.
Specialized Experience: Experience with specific types of medical devices or particular regulatory challenges.If you are passionate about managing clinical studies for state-of-the-art implantable medical devices and energized by working with a world-class manufacturer, we would love to hear from you! Apply now
Please click to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.
To find out more about Real, please visit
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC(phone number removed) England and Wales
