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- Tasks: Manage global clinical compliance projects and ensure client objectives are met.
- Company: Join ARC, a Belfast-based leader in precision medicine clinical trials.
- Benefits: Enjoy free car parking, competitive salary, and private health insurance.
- Why this job: Be part of a dynamic team transforming patient access to life-saving medicines.
- Qualifications: Undergraduate degree in biological sciences and 3+ years of relevant experience required.
- Other info: On-site role in Belfast; must commute daily.
The predicted salary is between 48000 - 72000 £ per year.
ARC's purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients. We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world's leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients' IND/IMP trial.
ARC's team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable. To further support our growing client base and to expedite patient access to life-saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360. ARC360 is transforming how organisations access regulatory intelligence and tailor study-specific information for using in vitro diagnostics to select and manage patients in IND trials. Powered by cutting-edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials.
Job Purpose
To be an integral member and significant contributor to project team(s) in the development and delivery of global clinical compliance solutions to client companies, ensuring that client objectives are met and exceeded at all times. This will require the utilisation of a platinum standard approach to clinical research, internal and external stakeholder satisfaction as well as an innate work ethic that is aligned with the company's core values.
Key Responsibilities:
- Research and prepare clinical elements of regulatory submission documents on behalf of client companies, including but not limited to CPSPs, IB's & Annex XIV submissions, Study risk determination requests, IDE submissions, and IRB/REC Submissions.
- Assist wider team in understanding the clinical operations requirements for an investigational IVD in the set-up, management & conduct of IVD clinical investigations worldwide.
- Prepare clinical affairs/operations quality management system audit reports and gap analyses on behalf of client companies.
- Contribute to the preparation and/or delivery of global clinical research guidance documents, conference presentations, webinars, white papers and other company-developed materials as required.
- Ongoing project budget management and tracking.
- Design and deliver formal client presentations, including proposed solutions.
- Contribute to ARC company culture initiatives to maintain a positive and engaging workforce.
Minimum Requirements:
- Undergraduate degree in biological sciences or other related scientific subject.
- Minimum 3+ years of IVD medical device clinical affairs/R&D experience in a similar role or 3-year post-doc experience in a relevant research subject.
- Demonstrable awareness of the requirements of clinical performance studies in accordance with the EU IVDR, as well as relevant regulations (eg: ISO 20916, 21 CFR).
- Demonstrable awareness of IRB/IEC (ethics) submission requirements.
- Experience in generating and reviewing documents relevant to clinical studies (eg: Strategy, Clinical Protocol, Monitoring Plans, Monitoring Reports).
- Proof of Right-to-Work in the UK.
- Must be able to commute daily to Belfast as the job is on-site.
- Postgraduate degree in biological sciences or other related scientific subject.
- Prior experience working in a rapid-growth, SME environment.
- Experience in clinical research regulatory requirements for companion diagnostics in the US.
- Strategic planning for IVD clinical studies, including identification and qualification of suitable clinical investigation sites.
- Experience in risk management and CAPA systems.
- Experience with eDC and eTMF platforms.
- Experience working with NHS R&D.
Skills: Clinical Monitoring, Clinical Research
Benefits: Free Car Parking, Competitive Salary, Private Health Insurance
Clinical Project Manager employer: ARC Regulatory
Contact Detail:
ARC Regulatory Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Project Manager
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines related to IVD clinical studies, especially the EU IVDR and ISO standards. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance excellence.
✨Tip Number 2
Network with professionals in the clinical research field, particularly those who have experience with IVDs. Attend relevant conferences or webinars to connect with industry experts and gain insights that could set you apart from other candidates.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences in managing clinical trials or regulatory submissions. Highlight your strategic planning skills and how you've successfully navigated challenges in previous roles.
✨Tip Number 4
Showcase your understanding of ARC's mission and values during your interactions. Tailor your conversations to reflect how your personal work ethic aligns with their commitment to patient access and compliance excellence.
We think you need these skills to ace Clinical Project Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Clinical Project Manager position. Familiarise yourself with the specific skills and experiences that ARC is looking for, such as IVD medical device experience and knowledge of clinical performance studies.
Tailor Your CV: Customise your CV to highlight relevant experience in clinical research and project management. Emphasise your familiarity with regulatory compliance, clinical operations, and any specific projects that align with ARC's focus on precision medicine.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for precision medicine and your understanding of ARC's mission. Mention how your background aligns with their goals and how you can contribute to their success.
Showcase Relevant Achievements: In both your CV and cover letter, include specific examples of past achievements that relate to the job description. Highlight your experience in managing clinical trials, preparing regulatory documents, and any successful projects that demonstrate your ability to meet client objectives.
How to prepare for a job interview at ARC Regulatory
✨Know Your Regulations
Familiarise yourself with the EU IVDR and relevant regulations like ISO 20916 and 21 CFR. Being able to discuss these in detail will show your understanding of the clinical performance studies required for the role.
✨Showcase Your Experience
Prepare specific examples from your past roles that demonstrate your experience in IVD medical device clinical affairs or R&D. Highlight any projects where you successfully managed compliance or contributed to regulatory submissions.
✨Understand the Company Culture
Research ARC's company culture and values. Be ready to discuss how your work ethic aligns with their core values and how you can contribute to maintaining a positive and engaging workforce.
✨Prepare for Client Presentations
Since the role involves delivering formal client presentations, practice articulating your ideas clearly and confidently. Consider preparing a mock presentation on a relevant topic to showcase your communication skills.
