An opportunity has opened for a Clinical Project Manager to join a small medical devices company based in Cambridge, UK on a permanent basis. Our client is in the process of expanding their Clinical Operations team and as a result, they're looking for their 2nd Clinical Operations hire who will report directly into the Head of Clinical Operations which means you'll be highly visible within the company.
This is a dynamic position with varied responsibilities - from day-to-day Project Management of the Class II/ III device trials, whilst being involved in writing study protocols and being hands on with ethics submissions. There's tonnes of room for growth in this position so this will suit somebody who is looking for a creative role where they can develop in the future.
This is a hybrid working model in central Cambridge (1 to 3 days per week in the office) so they need someone who can commit to this.
Key duties & responsibilities
- Writing project charters, study protocols and ethics submissions; assisting with governance paperwork; and managing these pre-study processes to completion.
- Conducting project site initiation visits.
- Delivering site onboarding including study staff training.
- Developing and maintaining relationships with key study site teams.
- Assisting in developing and running the study monitoring process including tracking data quality, patient recruitment, issues tracking and management, and providing progress updates to senior management.
- Supporting the operations and quality teams in order fulfilment and maintaining traceability of all stock involved in clinical projects.
- Supporting to identify and manage non-conforming products and medical device issues.
- Managing the complaints and feedback process.
- Providing support for other activities linked to clinical research and regulatory work including: supporting literature searches, abstract/paper reviewing/writing.
- Assist in planning and facilitating presentation of research output at conferences.
Skills & Competencies
Essential:
- Strong organisational and project management skills.
- Ability to multi-task, organise and prioritise work.
- Ability to think creatively and solve operational and logistical problems.
- Ability to deliver to tight deadlines, be comfortable with a changing environment, interruptions, and uneven workloads
- Excellent written and verbal communication and people skills; able to communicate complex concepts to different stakeholders.
- Attention to detail.
- Flexibility and willingness to support the broader team.
- Willingness to learn and develop processes.
- Good time keeping, punctuality and professional conduct.
- Strong team spirit and hands-on mentality.
- Proficient with Microsoft Word and Excel.
Desirable:
- Experience working within a quality management system (preferably ISO 13485 or ISO 9001).
- Experience working with medical device products, or experience working within a healthcare organisation.
Qualifications & Experience
Essential:
- Experience of managing and delivering clinical research studies or trials, including management of required trials paperwork and governance documentation.
- Project Management experience.
Desirable:
- Formal project management qualification e.g. Prince2, APM.
- Experience working within a quality management system (preferably ISO 13485 or ISO 9001).
- Experience working with medical device products.
- Qualified healthcare professional with clinical experience (and evidence of continued professional development).
- Experience of bid / grant / scientific writing.
What's on offer? A flexible basic salary, pension, flexible working hours plus much more!
If you are having difficulty in applying or if you have any questions, please contact Jack O'Neill at +44 203 8460 646.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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