Senior Clinical Research Specialist

Vita Global Sciences; Galway; On-site; EUR 70,000 - 100,000; Full time

Job summary

Vita Global Sciences in Galway, Ireland, seeks a Senior Clinical Research Specialist to lead and execute company-sponsored neurovascular clinical trials, ensuring regulatory adherence and timely milestones across countries.

Responsibilities include developing trial documents, coordinating sites and vendors, monitoring activities, and mentoring the team while contributing to publications and PMCF planning.

Qualifications

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

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.

Education

Bachelor's degree in Life Science or related field

BS with 4+ years, MS with 3+ years, or PhD with 2+ years of clinical research experience

Job description

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.