Clinical Study Lead

HIRANI; Belfast City District; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

HIRANI invites applications for a Clinical Lead to drive ARC’s Sponsor Delegation offerings, coordinating study design, regulatory compliance, and stakeholder engagement across global sites.

The role requires 3+ years in clinical settings within IVD/device manufacturing, with strong knowledge of GCP, IVDR, and regulatory frameworks, and a proven track record in study management.

Qualifications

• Undergraduate degree in biological sciences or related field.
• Minimum 3+ years of clinical experience in an IVD device manufacturer or sponsor context.
• Experience with regulatory requirements (IVDR, FDA) and quality systems.
• Proven ability to author or review clinical study documents and manage TMF/eTMF records.
• Proof of Right-to-Work in the UK.

Responsibilities

• Design and plan studies (timeline, resources and budget).
• Coordinate clinical operational activities with internal teams and clients.
• Develop/review regulatory documents (CSP, CSP, Investigator Brochure, Informed Consent).
• Manage client relations and issue resolution to ensure protocol compliance and data quality.
• Set up and track studies across regions; identify sites and coordinate site management.
• Apply regulatory and ethical approvals (GCP, IVDR, ISO13485 related).
• Prepare clinical study reports for regulators and ethics committees.

Skills

Stakeholder management

Regulatory knowledge

GCP

IVDR compliance

TMF/eTMF

Smartsheet

Education

Bachelor’s degree in biological sciences

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, internal and external stakeholder satisfaction as well as an innate work ethic that is aligned with the company’s 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 the 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, 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.

Undergraduate degree in biological sciences or other related scientific subject.

Minimum 3+ years 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.