Clinical Trial Manager

About 52North

Crowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards, 52North is a Medtech startup aiming to reinvent healthcare journeys for all people across the world.

Our mission is to help people live better lives, and we do this through innovating, collaborating, and using cutting-edge technology that centres around the people who will engage with it: those living with disease, care givers, doctors, paramedics or nurses. By integrating cutting-edge technology with a human-centred approach, we're dedicated to revolutionising patient experiences and setting new industry standards.

Our flagship product, Neutrocheck, was selected as one of a handful of technologies globally for the UK government’s first Innovative Devices Access Pathway (IDAP) pilot programme, providing direct and regular access to regulators and reimbursement authorities.

We are at an exciting and fast-paced stage of the company’s growth and are looking for a proactive and dedicated Clinical Trials Manager to join our collaborative and interdisciplinary team and provide overall management and oversight of 52North clinical trial activity. The successful candidate will work closely with cross-functional teams, including R&D, regulatory affairs, and product development, to ensure that clinical studies are conducted efficiently, in compliance with applicable regulations, and deliver high-quality data to support regulatory submissions and market access.

If you have strong clinical management and communication skills, and are passionate about state-of-the-art technology to make healthcare systems more efficient and transform the lives of patients around the world, apply now.

Position Overview

Key Responsibilities

As a clinical trial manager, you will work across two key areas:

Planning and preparation for clinical studies:

• Lead the planning and execution of clinical trials in accordance with UK and EU medical device regulations, Good Clinical Practice, SOPs, and any other applicable guidelines (e.g. regional/country requirements).
• Develop detailed project plans, including timelines, budgets, and resource allocation.
• Manage the preparation and submission of clinical trial protocols and regulatory documents

Managing the execution of clinical studies:

• Manage and establish collaborations with clinical trial sites
• Interact with the internal team, the Sponsor, study sites, and third-party vendors. Providing cross-functional oversight of internal project team members and deliverables
• Work closely with study PIs to achieve KPIs in relation to patient recruitment, screening and quality
• Serve as primary sponsor contact for operational project-specific issues and study deliverables
• Develop operational project plans
• Manage trial budgets, resources, risk assessment and execution
• Responsible for management of study vendors, sites, and data
• Communication and collaboration, ensuring regular updates to 52North senior leadership on trial progress and milestones, preparing and presenting trial status reports.
• Support the writing of clinical manuscripts for publication
• Prepare abstracts, power-point presentations and posters for presentations to external stakeholders and submission to scientific conferences.

Qualifications and experience

Essential

• Bachelor’s degree in a health and life science-related field; Advanced degree in a health or life science-related field preferred
• Minimum of 2 years of experience in managing clinical trials
• Proven clinical trial experience, clinical trial management; and operations for commercial trials
• Evidence of preparing regulatory and ethics submissions, IRAS submissions, writing/amending Clinical Investigation Plans, Patient Information Forms and electronic Case Report Forms, plus other relevant trial management documentation.
• Good Clinical Practice (GCP) training
• Ability to work well within a team within a fast-paced environment
• Excellent project management skills within clinical trial management
• Excellent communication skills, both verbal and written, with the ability to interact effectively with internal teams, clinical sites, and regulatory bodies.
• Strong problem-solving skills and ability to adapt to a fast-paced, changing environment.
• Attention to detail and strong organisational skills.

Preferred

• Experience in trial management for Software as a Medical Device products and/or connected devices
• Experience in Medical Device trials
• Working knowledge of ISO 20916.
• Demonstrated knowledge of global regulatory requirements (e.g., FDA, MDR/IVDR)

Benefits

At 52North, we believe that our team should be taken care of both in and outside of the office. We offer a robust benefits package, carefully designed to ensure our team members are supported in all aspects of their lives. Our benefits include:

• Hybrid Working: Enjoy the flexibility of working from home or in our beautiful office space.
• Flexible Schedule: We understand that everyone has different needs and rhythms. That is why we offer a flexible work schedule.
• Generous Holiday Allowance: We offer 28 days of paid holiday plus bank holidays every year. On top of that, you will get an extra day off for every two years of service with us.
• Maternity, Paternity and Adoption Policies: We have comprehensive policies for maternity, paternity, shared parental leave and adoption to support our team members in these life-changing moments.
• EMI Share Option Scheme: We want our team to be part of our long-term success, so we provide a participation in an EMI share option scheme.
• Pension Scheme: We offer a NEST pension scheme with generous employer contributions.
• Health Insurance: Our health insurance provides generous coverage, including physiotherapy, mental health services, and unlimited virtual GP consultations.
• Dental and Optical Coverage: We cover dental and optical expenses because we know how important complete healthcare is.
• Wellbeing Engagement Programme: We promote a healthy lifestyle by providing a 50% discount on certain gym memberships and other wellness resources.
• Social Activities: We foster a close-knit community with social activities throughout the year and multi-day group retreats.
• Office Perks: Our office is a 15-minute walk from the historical city centre of Cambridge, well connected with public transport and Park & Ride. Enjoy free biscuits, cake, tea, and coffee and soak in the beautiful countryside views that our office offers.

52North is an equal opportunity employer and is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other characteristics protected by law.

Join us at 52North and enjoy these benefits as you work in an environment that fosters growth and encourages work-life balance.