Clinical Study Lead

HIRANI; Belfast; On-site; GBP 42,000 - 58,000; Full time

Job summary

Une entreprise centrée sur l'innovation recherche un Clinical Lead pour diriger des projets cliniques liés à leur offre de délégation de parrainage. Le candidat idéal aura une solide expérience en gestion de projets cliniques, notamment dans la conception et la mise en œuvre d'études, ainsi qu'une connaissance approfondie des exigences réglementaires. Ce rôle est crucial pour garantir le succès des objectifs des clients, tout en maintenant la qualité et la sécurité des données.

Qualifications

• Minimum de 3+ années d'expérience clinique dans un fabricant de dispositifs IVD ou environnement pharmaceutique/biomédical.
• Connaissance des exigences réglementaires et des pratiques sectorielles.
• Expérience dans un environnement SME rapide, de préférence en oncologie ou CDx.

Responsibilities

• Conception d'études, gestion des ressources et des budgets.
• Coordination des activités opérationnelles cliniques avec des parties prenantes internes.
• Développement et révision de la documentation pour assurer la conformité.

Skills

Gestion de projet

Connaissance des exigences réglementaires

Résolution de problèmes

Gestion client

Collaboration avec des parties prenantes

Education

Diplôme de premier cycle en sciences biologiques ou domaines liés

Diplôme de troisième cycle préféré

Tools

TMF/eTMF

Smartsheet

Job description

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:

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