Clinical Project Specialist
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Employment Type: Full-Time (40 hours/week)
Contract: 12-Month Fixed-Term
About the Company
This position is with a leading global manufacturer of advanced medical devices, specialising in innovative solutions to improve cardiac and vascular health. With a longstanding reputation for research-driven development and quality, the organisation delivers transformative technologies to healthcare providers worldwide.
Position Overview
The Clinical Project Specialist will support the launch and management of a high-impact clinical device study, currently in the pipeline and awaiting final approval. This role focuses on hands-on project coordination, particularly in overseeing subject selection committee activities and vendor collaboration, ensuring rigorous compliance with international clinical standards.
Main Duties & Responsibilities
- Coordinate subject selection committee processes, acting as a key point of contact for stakeholders and ensuring protocols are followed.
- Monitor and communicate data collection needs to research sites, labs, and colleagues; drive adherence to project schedules.
- Organise adjudication activities, both remotely and through virtual meetings, facilitating discussion and review between committee members and investigators.
- Provide support for image processing and presentation preparation for committee review sessions.
- Share committee findings and decisions efficiently with site teams and internal staff; maintain clear lines of communication.
- Track consulting hours for committee participants to streamline consultant compensation.
- Uphold high standards of clinical documentation: timely data entry, secure archiving, and effective records management.
- Work collaboratively with clinical research, field, and site teams to keep case reviews on track.
- Offer input for enhancements to study protocols, training resources, and committee procedures.
- Drive project milestones and database closure activities, maintaining deliverable timelines alongside study teams.
Qualifications & Background
- Minimum 3 years’ experience in clinical research or operations within the medical device industry.
- Advanced skills in clinical data assessment and project timeline management.
- Exceptional written and verbal communication, organisational, and analytical skills.
- Proficiency in Microsoft Office and relevant clinical software platforms.
- Ability to operate independently with attention to regulatory and process detail.
Preferred Attributes
- Experience with cardiac or vascular medical technology.
- Previous involvement in clinical research within either a laboratory or corporate context.
- Professional certification in clinical research (e.g., SoCRA or ACRP).
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