Job Specification
Position: Freelance Clinical Study Lead – Companion Diagnostic Clinical Studies
Contract: 6 months (Freelance/Consultant)
Location: Fully Remote
Role Overview
We are seeking an experienced Clinical Study Lead to support companion diagnostic clinical studies on a 6-month freelance contract. This role is fully remote and requires prior experience in the diagnostics sector. The Clinical Study Lead will be responsible for the planning, execution, and oversight of clinical performance studies, ensuring compliance with regulatory standards, company SOPs, and project timelines.
Key Responsibilities
Lead and oversee clinical studies for companion diagnostics.
Develop and execute study-related documentation, including protocols, investigator brochures, informed consent forms, contracts, and reports, in compliance with regulations, guidelines, and SOPs.
Represent the Clinical Affairs function in cross-functional internal teams and with external stakeholders such as pharma partners and central labs.
Ensure study sites, equipment, and staff training are fully compliant with the clinical protocol and organisational SOPs.
Lead and mentor the clinical sub-team (CRA, CTA), including delivering project-specific training and hosting regular team meetings.
Support preparation and submission of performance study applications for EU IVDR to NCAs/ECs, and manage responses to RFIs.
Requirements
Hard Skills
Master’s degree in Life Sciences, Biomedical Sciences, or related field (PhD preferred).
5-8 years of experience in diagnostics (in vitro diagnostic devices required); experience in other devices or pharmaceutical environments will also be considered.
Minimum 3 years’ experience in Clinical Affairs/Operations preferred; product development, quality, or regulatory experience considered as part of overall profile.
Proven experience in clinical study management and knowledge of Good Clinical Practice.
Strong background in designing and authoring clinical performance study protocols and reports (highly preferred).
Familiarity with regulatory requirements (FDA CFR, ICH GCP, IVDR).
Proficiency with Microsoft Word, Excel, and clinical operations systems (e.g., eDC, eTMF, CTMS).
Excellent command of English, both oral and written.
Soft Skills
Excellent communication skills, verbal and written.
Strong interpersonal skills and ability to collaborate across diverse teams.
High attention to detail with strong organisational abilities.
Independent, proactive worker with sound judgment and decision-making skills.
Demonstrated ability to foster a high-performance, high-standards culture.
Effective problem-solving and stakeholder management skills.
Strong planning and coordination abilities across multiple stakeholders.
Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.
