- Lead the execution of clinical studies to ensure high-quality data is delivered on time and within budget.
- Design strategies for clinical trial applications.
- Evaluate safety events critically.
- Provide medical guidance to both internal and external stakeholders.
- Own technical files and collaborate across functions.
- Plan and review clinical trials and design protocols for new devices.
- Analyse data from clinical studies and present findings.
- Train internal personnel.
- Assist with risk management and post-market surveillance activities.
- Write and edit clinical and scientific reports for regulatory submissions.
- Build relationships with influential thought leaders in the medical community.
- Review and approve product as part of the new product development process.
- Develop and maintain clinical SOPs to ensure best practices across the department. Key Skills and Requirements:
- Leadership and communication skills.
- Knowledge of US FDA trial design and submissions.
- Ability to design cost-effective clinical studies.
- Ability to communicate complex technical information to non-technical audiences.
- A medical degree or equivalent professional qualification.
- Knowledge of US and international standards and regulations for clinical research.
- Experience authoring technical documentation.
- Proficiency in the use of MS Office suite.
- Experience in a fast-paced and high-energy environment.
- Ability to handle confidential information with discretion.
- Excellent judgment and ability to switch gears at a moment's notice.
- Experience in a global business environment is a plus.
- Experience in a start-up environment and with IVD devices, especially self-test devices, is desirable. Interested or know someone who might be? Reach out to Rachel Salisbury using the following: Apply now:
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.
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Clinical Affairs Manager - California, United States - Hobson Prior
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Description
Hobson Prior is seeking a Clinical Affairs Manager. This role is crucial in providing medical expertise, support and guidance on healthcare products. The successful candidate will be part of the Quality & Regulatory global department and will have the opportunity to lead a team. This role involves collaboration with leaders across various functions globally.
Responsibilities:
