At ARC Regulatory, our experienced team is passionate about supporting the advancement of high-quality biomarker testing in precision medicine research. Our work on +40 precision medicine programmes across oncology, auto immune and cardiac therapy biomarkers, has helped deliver robust clinical data to expedite successful regulatory submissions and global market launches for pharma, laboratory and IVD clients, big and small.
ARC Regulatory continues to create a reputation as a "Great Place to Work". Our commitment centres around employee wellbeing. We enjoy a clearly defined company culture that puts team members, clients and patients, whose lives we seek to improve, at the centre of our day. ARC’s investment in career development means there is a career path available and each employee strengthens his/her knowledge of the complex regulatory environment for IVD and CDx medical devices.
Senior Clinical Project Manager (Devices and Diagnostics)
Job Purpose:
To be an integral member and significant contributor to project team(s) in the development and delivery of global 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 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:
· Lead the work of the company and project teams in the provision of specialised clinical research assistance to client companies, ensuring expectations and interests are met.
· Contribute to the formulation and implementation of the short and medium-term Key Performance Indices/Indicators that allow for measurement of success.
· Research and prepare elements of clinical regulatory submission documents on behalf of client companies, including but not limited to CTA’s, Study risk determination requests, IDE submissions, IRB/REC Submissions.
· Contribute to the wider team’s in understanding the clinical operations requirements for an investigational device in the set-up, management & conduct of device clinical investigations worldwide.
· Prepare clinical affairs/operations quality management system audit reports and gap analyses on behalf of client companies.
· Work to manage and prioritise actions relevant to direct reports workload, internal process development and client deliverables.
· Contribute to the preparation of global clinical research guidance documents and white papers.
· Take advantage of professional networking opportunities in order to promote the company and its services to appropriate parties.
· Design and deliver formal client presentations, including proposed solutions.
· Identify & undertake continuing professional development linked to personal objectives to ensure ongoing awareness of current quality and regulatory standards.
· Any other duties, within reason and capability, as determined by the Management
Qualifications/ Attainments
· Engineering or Scientific degree at 2:2 honors or above
· MSc or PhD in science related subject
Relevant Knowledge and Experience
· 3+ years relevant medical device or IVD medical device industry experience or 5+ years relevant industry experience in life sciences or healthcare research
· Experience of risk management and CAPA systems
· Experience of developing quality management system documentation relevant to regulatory and/or clinical affairs
· Awareness of global regulatory submission requirements (e.g. EU/FDA/Health Canada)
· Awareness of regulatory requirements in emerging markets (e.g. Asia/South America)
· Experience of clinical research regulatory requirements for companion diagnostics in the US or EU
· Experience of planning and conducting clinical performance evaluations for in vitro diagnostic medical devices
· Experience of generating and reviewing documents relevant to clinical studies: Strategy, Clinical Protocol, Monitoring Plans, Reports etc.
· Strategic planning for clinical studies including identification of and qualification of suitable clinical investigation sites
· Experienced in setting up global clinical investigation sites
Skills and Competencies
· Excellent communication skills, both verbal and written, including strong presentation and influencing skills
· Evidence of strong analytical, problem solving and decision-making abilities
· Evidence of well-developed organisational, planning and time management abilities
· Proven ability to achieve results while working independently and on own initiative
· Strong mathematical ability
· Proficient in the use of word processing, spreadsheet, database and presentation software
Circumstances
· Able to work flexibly as required to ensure business needs are met
· Valid full driving licence and vehicle insured for business use
· Able to travel as required, including European and possibly global travel
· Valid passport
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