At {company}, we expedite access to precision medicine clinical trials for patients worldwide.
We are a Belfast-based Clinical Research Organisation specialising in delivering compliance excellence for companies in the precision medicine sector.
Job Purpose
To be an integral member and Clinical Lead of project teams in the development and delivery of ARCs Sponsor Delegation offering to client companies, ensuring client objectives are met and exceeded.
This requires a platinum standard approach to clinical research project management, internal and external stakeholder satisfaction, and an innate work ethic aligned with our core values.
Key Responsibilities
* Study design, strategy, planning (timeline, resources, and budget management)
* Coordinating clinical operational activities with internal stakeholders and clients, including pharma company and central testing laboratories conducting studies
* Development and/or review of associated documentation, including documents such as CPSP, CSP, investigator brochure, informed consent for devices, risk-based monitoring plan, and reports, in compliance with relevant regulations, guidelines, and SOPs
* Client management, issue resolution, troubleshooting, and ongoing coordination between all relevant groups to maintain compliance to protocol, patient safety, and robust data collection, and provision of regular updates to project progression
* Set up, manage, and track studies, supporting study completion within agreed timelines and budget
* Identify and enlist suitable study sites, and coordinate site management activities, with site audit, Site Qualification Visit, and study set up across USA, EU, and Asia/Pac regions
* Understanding and application of relevant regulatory requirements and ethical approvals for conducting studies (e.g. IVDR requirements for EU, FDA requirements for USA, GCP, ISO20915)
* Managing the study close-out activities, including essential documentation filing and completion between study testing site(s) and sponsor TMF, ethical and regulatory bodies notification of study close, and study close-out report
* Generation of clinical study reports and related documentation to submit to regulatory authorities, ethical review boards, and local agencies such as national competent authority
Requirements
* Undergraduate degree in biological sciences or other related scientific subject
* Minimum 3+ years of clinical experience in an IVD device manufacturer; other devices or pharmaceutical experience in the capacity of device sponsor will be considered
* Demonstrable knowledge of regulatory requirements and industry practices (e.g. IVDR, FDA, GCP, ISO14155, ISO20916, ISO13485, and QMS design control)
* Experience of using TMF and/or eTMF and Smartsheet (or equivalent) software
* Experience of authoring clinical study documents (e.g. Clinical Strategy, Data Management Plan, CPSP, CSP, Investigator Brochure, Risk-based Monitoring Plan, Informed Consent Documents)
* Proof of Right-to-Work in the UK
* Must be able to commute daily to Belfast as the job is on-site
Desirable Criteria
* Postgraduate degree in biological sciences or other related scientific subject
* Prior experience working in a rapid growth, SME environment
* Specific experience within oncology, IHC, NGS, or molecular CDx