Senior Clinical Research Scientist
Our Galway based client, a Medical Device Manufacturing organisation are currently recruiting for a Senior Clinical Research Scientist to join their growing team on a permanent basis.
• Develop and Draft Clinical Trial Protocols, Informed Consents, Investigator Brochures, and other Study Materials for Neurovascular Studies
• 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
• Responsible for Critically Assessing the literature
• Develop Strong Relationships with key investigators to drive clinical study execution and deliver evidence
• Evaluate the Marketability and Medical Usefulness of drug and product candidates
• Bachelor’s Degree in Biological Science or related discipline, with a Minimum of 4 Years Related Clinical Research Experience, MSc, PhD would be desirable
• 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
• Second language of French or Spanish would be desirable
If you would like further Information you can contact the recruiter directly:
Sinead Cullen | Tel: +353 (0) 1 507 9252