My medical device manufacturing client is a global leader in neurovascular care.
They offer a broad portfolio of devices used in the endovascular treatment of haemorrhagic and ischemic stroke.
The purpose of this role is to plan and monitor clinical evaluation projects. It will involve travelling Europe for 70-80% of the time to develop research in clots/neurotechnology with clinicians and doctors.
- You will Develop and Draft Clinical Trial Protocols, Informed Consents, Investigator Brochures, and other Study Materials for Neurovascular Studies with minimal supervision.
- Plan for Study Budgets and collaborate with Clinical Operations to manage the development of Investigator Agreements and Site Contracts.
- Deliver Assigned Clinical Programs, through effective partnership with Clinical Operations, Biostatistics and Data Management.
- Ensure Study Progress for assigned projects and that issues are identified and communicated to leaders.
- Draft Study Reports to include any annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions.
- Ensure Input and Strong Alignment from key regional MD, Clinical, R&D Leads and other strategically important countries/regions in the development of the clinical evidence generation and dissemination strategies.
- Be Responsible for Critically Assessing the literature.
- Foster Strong Relationships with key investigators to drive clinical study execution and deliver evidence.
- You will Evaluate the Marketability and Medical Usefulness of drug and product candidates.
- You will need a Bachelor’s Degree in Biological Science or related discipline, with a Minimum of 4 Years Related Clinical Research Experience Or with a Masters or PhD these requirements respectively would be required.
- Clinical Research Experience within the medical device industry is required.
- Experience including involvement with Investigational Device Exemption (IDE) trials is required.
- Knowledge and experience Writing Clinical Protocols and reports is required.
- Ability to Provide Scientifically Strategic and Scientific Clinical Research input across new product development and life-cycle management projects is preferred.
- Proven Track Record in Delivering Clinical Projects within clinical research setting, on time, within budget and in compliance to SOPs and regulations is preferred.
- Ability to Lead Study Teams to deliver critical milestones is preferred.
- Demonstrated ability to Build Collaborative Relationships with key internal and external partners and stakeholders is preferred.
- Knowledge and experience in Neurovascular is preferred.
- Up to 70% to 80% Travel may be required.
To apply for this position please contact Amanda Reynolds at Sigmar Recruitment T: +353 91 455304 E: firstname.lastname@example.org
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