Quality Specialist – Decentralised Clinical Trials

Quality Specialist – Decentralised Clinical Trials

• Location: Cork – Hybrid
• Contract: 12 months
• Start Date: ASAP
• Onsite Requirement: Approximately 50%, typically 2–3 days per week, with Monday as a core onsite day

Baker Finn Recruitment is supporting a leading pharmaceutical organisation in the appointment of a Quality Specialist to join its Decentralised Clinical Trials Quality team.

This position will provide Quality support and oversight for innovative clinical trial capabilities designed to make participation more accessible to patients. These may include direct-to-patient delivery of clinical trial medicines, mobile healthcare services, telemedicine, site staffing solutions, pharmacy involvement and other services delivered by external providers.

As decentralised clinical trials are an evolving area, the successful candidate must be comfortable interpreting Good Clinical Practice principles, assessing risk and making sound Quality decisions in situations where guidance may not always be completely prescriptive.

Key Responsibilities

• Provide Quality support and oversight for decentralised clinical trial activities.
• Oversee third-party vendors delivering clinical trial services on behalf of the sponsor.
• Assess vendor activities, Quality processes and associated compliance risks.
• Ensure outsourced clinical trial activities meet relevant GCP and Quality requirements.
• Apply Quality principles and professional judgement where regulations or internal guidance are not explicit.
• Identify, assess and support the mitigation of Quality and compliance risks.
• Work closely with clinical, operational and cross-functional stakeholders.
• Provide constructive challenge and ask appropriate questions when evaluating new or evolving trial capabilities.
• Support risk-based decision-making and determine suitable levels of vendor oversight.
• Promote a strong Quality culture across internal teams and external service providers.

Candidate Requirements

• Strong working knowledge of Good Clinical Practice (GCP).
• Experience within clinical research, clinical operations or a related Quality function.
• A clear understanding of sponsor responsibilities and how clinical trials operate in practice.
• Experience in vendor management, third-party oversight, supplier Quality or CRO oversight.
• Strong risk assessment, problem-solving and critical-thinking skills.
• Ability to interpret regulations and apply Quality principles in situations without a straightforward answer.
• Confidence working independently and making well-reasoned Quality decisions.
• Strong communication and stakeholder-management skills.
• Full working rights in Ireland.

Highly Desirable

• Experience working at or closely with clinical trial sites.
• Knowledge of site-facing or patient-facing clinical trial services.
• Experience overseeing outsourced activities in a regulated clinical environment.
• Familiarity with decentralised clinical trials, telemedicine or remote trial activities.
• Exposure to computerised systems or technology used within clinical trials.

The Ideal Candidate

The ideal candidate will combine strong GCP knowledge with a practical understanding of clinical trials and third-party oversight. They will be comfortable “navigating the grey”, applying judgement and assessing situations from a Quality and risk perspective rather than relying solely on prescriptive procedures.

This is an excellent opportunity to support an innovative and growing area of clinical research within an experienced, collaborative Quality team.

Please note that this is an initial 12-month contract. Any opportunity beyond the initial term will depend on future business requirements and cannot be guaranteed.