Medical Information jobs in Ballybrit, County Galway

Location: Galway, Ireland

Contract: 12 months with possible extension

Kelly FSP is seeking a Senior Clinical Research Specialist to provide dedicated expertise supporting clinical trials within a leading Neurovascular Clinical R&D Department. This role fosters strong, productive relationships throughout the organization and ensures successful execution of clinical studies.

Duties & Responsibilities:

• Serve as a Senior Clinical Research Specialist to support execution of company-sponsored clinical trials, ensuring compliance with timelines and study milestones for neurovascular clinical research.

• Oversee/execute feasibility, selection, setup, conduct, and closure of clinical trials within allocated countries, in accordance with ICH-GCP, applicable legislation, and company SOPs.

• Act as primary contact for clinical trial sites, including site management activities.

• Contribute to development of clinical trial documents (study protocols, informed consents, CRF, monitoring plans, study manuals, investigator brochures, annual reports, etc.).

• Support trial registration and manage posting of results and associated publications as needed.

• Manage ordering, tracking, and accountability for investigational devices and other trial materials.

• Collaborate with site personnel, IRBs/ECs, contractors/vendors, and internal teams.

• Oversee and support Clinical Research Associates (CRAs).

• Manage development and execution of Investigator agreements and trial payments.

• Review clinical data to prepare for statistical analyses and publications.

• Conduct monitoring activities, including site qualification, initiation, interim monitoring, and close-out visits as needed.

• Support global evidence generation strategies and evidence dissemination within assigned projects.

• Provide on-site procedural support and ensure protocol compliance at clinical trial sites.

• Critically assess literature and participate in interpretation and dissemination of evidence generated.

• Deliver assigned clinical projects, partnering with study teams to meet project goals (timelines, budget, compliance).

• Support development/review of Post-Market Clinical Follow-up (PMCF) Plans/Evaluation Reports and coordinate documentation as needed.

• Support project/study budget activities.

• Mentor team members.

• Maintain up-to-date project knowledge, acting as a reliable resource for stakeholders.

• Develop strong understanding of pipeline, product portfolio, and business needs.

• Work independently or with supervision based on project complexity; exercise good judgment in decision making.

• Communicate business-related issues and opportunities to management.

• Adhere to Health, Safety, and Environmental guidelines, ensuring compliance for self and supervised staff as applicable.

• Ensure compliance with all federal, state, local, and company regulations, policies, and procedures.

• Perform additional assigned duties as needed.

Clinical Safety Coordination (as assigned):

• Coordinate safety-related activities for clinical trials, including planning and implementation of new safety initiatives, development of safety management plans, and collaboration with stakeholders.

• Work with data management to ensure timely notifications, collection of safety event information, and compliance with reporting requirements.

• Create safety reports for internal/external stakeholders and coordinate safety board meetings and safety adjudication processes.

Experience and Education:

• Bachelor’s degree required, preferably in Life Science, Physical Science, Nursing, or Biological Science.

• BS with at least 4 years, MS with at least 3 years, or PhD with at least 2 years of relevant clinical research experience preferred.

• Previous experience in clinical research or equivalent required.

• Relevant industry certifications preferred (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).

• Clinical/medical background is a plus.

• Medical device experience highly preferred.