Hobson Prior are currently looking for a Senior Clinical Manager to join a small but growing Orthopaedic medical device client. You will be responsible for managing the Company’s clinical projects, post-market surveillance and associated clinical marketing activities. This is an exclusive role to be 100% homebased anywhere in the UK.
- Design, plan and implement clinical research projects in accordance with regional (e.g. EU, FDA) and ICH-GCP requirements.
- Manage all clinical study project elements from initiation to close-out.
- Develop protocols, Investigator Brochures, monitoring plans, case report forms, informed consents, study manuals and study budgets.
- Co-operate with CRO to manage and execute the clinical strategic operations plan for projects including timelines, resources and cost.
- Negotiate contracts and budgets with CRO and related third party vendors and CRAs.
- Negotiate site contracts and budgets and perform site visits at all stages throughout the clinical study.
- Review and/or submission of research ethics committee/regulatory documentation.
- Prepare Clinical Study Reports and annual safety reports.
- Manage existing and planned post-market surveillance activities and provide annual reports to meet regulatory requirements.
- Review monitoring activities and reporting for accuracy, completeness and conformance with SOPs.
- Develop clinical performance metrics and establish reporting frequency.
- Assist with the development and implementation of clinical downstream marketing tools.
- Co-operate with cross-functional teams to develop product launch plans.
- Can make objective and subjective decisions and use judgment in non-routine situations.
- Capability to build and manage a dynamic clinical strategy and expedite project delivery.
- Must have strong ability to plan, prioritize and execute.
- Be creative, recognise opportunities for improvement and maintain high standards for deliverables.
- Work effectively with cross-functional teams and external sub-contractors.
- Ability to effectively communicate (both verbally and in writing) in individual and group situations.
- Highly organized, self-motivated and with strong abilities to analyse and resolve problems.
- Bachelors Degree (B.S. or B.A.)
- Minimum of 5-10 years’ experience in medical device clinical study management, preferably involving Class III products.
- 2-5 years of post-market surveillance management and implementation.
- In-depth knowledge of medical device clinical evaluation in accordance with EU requirements.
- Knowledge and awareness of medical device clinical evaluation in accordance with USA FDA requirements.
- Competency in ICH-GCP and a strong interest in clinical research.
- Prior monitoring experience and/or co-monitoring experience is required.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.