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- Tasks: Lead global clinical compliance projects and ensure client objectives are met with excellence.
- Company: Join ARC, a Belfast-based leader in precision medicine clinical trials and regulatory compliance.
- 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 through innovative solutions.
- 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 42000 - 84000 £ 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, IBs & Annex XIV submissions, Study risk determination requests, IDE submissions, 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.
Essential Criteria:
- Undergraduate degree in biological sciences or other related scientific subject.
- Minimum 3+ years 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 of 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 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.
- Experience of 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 of risk management and CAPA systems.
- Experience of eDC and eTMF platforms.
- Experience of 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 Ltd
Contact Detail:
ARC Regulatory Ltd 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 during the hiring process.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that showcase your ability to manage clinical projects effectively. Highlight any instances where you exceeded client expectations or improved processes, as this aligns with ARC's focus on client satisfaction.
✨Tip Number 4
Research ARC's SaaS platform, ARC360, and understand how it transforms clinical trial processes. Being able to speak knowledgeably about their technology and its impact on the industry will show your genuine interest in the company and its mission.
We think you need these skills to ace Clinical Project Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Clinical Project Manager position. Understand the key responsibilities and essential criteria required, as this will help you tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in IVD medical device clinical affairs or R&D. Be specific about your roles and achievements that align with the responsibilities mentioned in the job description.
Showcase Your Skills: Make sure to highlight any relevant skills such as clinical monitoring, regulatory compliance, and project management. Use examples from your past work to demonstrate how you have successfully applied these skills in real-world scenarios.
Craft a Compelling Cover Letter: Write a tailored cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role and the company. Mention how your values align with ARC's mission to expedite access to precision medicine clinical trials.
How to prepare for a job interview at ARC Regulatory Ltd
✨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 compliance landscape in clinical research.
✨Demonstrate Your Experience
Prepare specific examples from your past roles that highlight your experience in IVD medical device clinical affairs or R&D. Be ready to discuss how you've managed clinical studies and ensured compliance.
✨Showcase Your Communication Skills
As a Clinical Project Manager, you'll need to communicate effectively with various stakeholders. Practice articulating complex information clearly and concisely, especially when discussing clinical protocols or regulatory submissions.
✨Engage with Company Culture
Research ARC's company culture and values. Be prepared to discuss how you can contribute to maintaining a positive and engaging workforce, as this aligns with their core objectives.
