Clinical Study Lead

To be an integral member and Clinical Lead to project team(s) in the development and delivery of ARC’s Sponsor Delegation offering to client companies, ensuring that client objectives are met and always exceeded. This will require the utilisation of a platinum standard approach to clinical research project management, stakeholder satisfaction, and a strong work ethic aligned with the company’s core values.
Key Responsibilities:

Study design, strategy, and planning (timeline, resources, and budget management).
Coordinating clinical operational activities with internal stakeholders and clients, including pharma companies and laboratories.
Development and review of documentation such as CPSP, CSP, investigator brochure, informed consent, risk-based monitoring plan, ensuring compliance with regulations and SOPs.
Client management, issue resolution, troubleshooting, and coordination to maintain protocol compliance, patient safety, and data quality, with regular project updates.
Setup, management, and tracking of studies to support completion within timelines and budget; site identification, qualification, and management across regions.
Understanding and application of relevant regulatory and ethical requirements (e.g., IVDR, FDA, GCP, ISO standards).
Managing study close-out activities, documentation filing, regulatory notifications, and close-out reports.
Generation of clinical study reports for regulatory submissions and reviews.
Requirements include an undergraduate degree in biological sciences or related fields, with a postgraduate degree preferred.
Minimum of 3+ years clinical experience in an IVD device manufacturer or related pharmaceutical/medical device environment.
Knowledge of regulatory requirements and industry practices (e.g., IVDR, FDA, GCP, ISO standards).
Experience with TMF/eTMF, Smartsheet or similar software, and authoring clinical study documents.
Proof of Right-to-Work in the UK and ability to commute daily to Belfast, as the role is on-site.
Experience in a fast-paced SME environment and within oncology, IHC, NGS, or molecular CDx is preferred.

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