Clinical Trial Manager

3 weeks ago

Cambridge UK, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full time

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.

  • Clinical Trial Manager

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Clinical Trial Manager Job DescriptionWe are seeking a highly skilled Clinical Trial Manager to support our team in planning, implementing, and overseeing clinical trials. As a Clinical Trial Manager, you will be responsible for communicating effectively with internal and external study personnel and facilitating the activities associated with the successful...

  • Clinical Trials Manager

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Healthcare Businesswomen's Association Full time

    Job SummaryWe are seeking a highly skilled Clinical Trials Manager to lead our global study teams and ensure the successful execution of clinical trials. The ideal candidate will have a strong background in clinical research and experience in managing cross-functional teams.Key ResponsibilitiesLead global study teams to ensure timely and successful trial...

  • Clinical Trial Manager

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Clinical Trial Manager Job DescriptionWe are seeking a highly skilled Clinical Trial Manager to join our team at Bicycle Therapeutics. As a Clinical Trial Manager, you will play a crucial role in planning, implementing, and overseeing our clinical trials.Key Responsibilities:Lead cross-functional clinical study teams to ensure successful trial implementation...

  • Clinical Trial Manager

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Clinical Trial Manager Job DescriptionBicycle Therapeutics is seeking a highly skilled Clinical Trial Manager to join our team. As a Clinical Trial Manager, you will be responsible for planning, implementing, and overseeing clinical trials to ensure their successful execution.Key Responsibilities:Lead cross-functional clinical study teams to ensure...

  • Clinical Trial Manager

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job SummaryWe are seeking a highly skilled Clinical Trial Manager to join our team at Bicycle Therapeutics. As a key member of our Clinical Operations group, you will play a critical role in planning, implementing, and overseeing our clinical trials.Key ResponsibilitiesLead cross-functional clinical study teams to ensure successful trial implementation and...

  • Clinical Trial Coordinator

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Trial Administrator to provide administrative support and maintain essential clinical documentation for MoonLake sponsored clinical studies.The ideal candidate will have experience of clinical trials as a clinical trial administrator or clinical trial coordinator and a working...

  • Senior Clinical Trials Manager

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Merus Netherlands Full time

    The Clinical Operations TeamWe are seeking a highly experienced Senior Clinical Trials Manager to join our Clinical Operations team. As a key member of our team, you will be responsible for ensuring the successful execution of our clinical trials.Manage clinical study material, oversee vendors, and assist in the implementation plan(s);Assist in authoring...

  • Clinical Trials Coordinator

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Clinical Trial ManagerJob Summary: We are seeking a highly skilled Clinical Trial Manager to support our team in planning, implementing, and overseeing our clinical trials. The ideal candidate will have strong organizational and analytical skills, excellent communication abilities, and experience in clinical trial management.About the Role: As a Clinical...

  • Clinical Trial Coordinator

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom NHS Blood and Transplant Full time

    Job Title: Clinical Trial CoordinatorAn exciting opportunity has arisen for a highly motivated and organized Clinical Trial Coordinator to join our team in Cambridge. As a key member of our Clinical Trials Unit, you will play a vital role in supporting the management of clinical trials from set up to close down.Key Responsibilities:Assist with the management...

  • Clinical Trial Coordinator

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job OverviewMoonLake Immunotherapeutics is seeking a highly organized and detail-oriented Clinical Trial Administrator to provide administrative support and maintain essential clinical documentation for MoonLake sponsored clinical studies.This role will involve providing document management and filing support, preparing document review forms, tracking and...

  • Clinical Trial Coordinator

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job OverviewMoonLake Immunotherapeutics is seeking a highly organized and detail-oriented Clinical Trial Administrator to provide administrative support and maintain essential clinical documentation for MoonLake sponsored clinical studies.The successful candidate will be responsible for:Providing document management and filing support for MoonLake Clinical...

  • Clinical Trial Coordinator

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job OverviewMoonLake Immunotherapeutics is seeking a highly organized and detail-oriented Clinical Trial Administrator to provide administrative support and maintain essential clinical documentation for our sponsored clinical studies.This is an exciting opportunity to join our dynamic and innovative team and contribute to ground-breaking projects that have...

  • Senior Clinical Trials Coordinator

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Cambridge University Hospital NHS Foundation Trust Full time

    Job SummaryWe are seeking a highly skilled Senior Clinical Trials Coordinator to join our team at Cambridge University Hospitals NHS Foundation Trust. As a key member of our research team, you will be responsible for coordinating and managing a portfolio of clinical trials, ensuring that all research activities are conducted in accordance with Good Clinical...

  • Clinical Trials Pharmacy Specialist

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Royal Papworth Hospital NHS Foundation Trust Full time

    Job Summary We are seeking a highly skilled and experienced Pharmacy Technician to lead our Clinical Trials team at Royal Papworth Hospital NHS Foundation Trust. As a key member of our pharmacy department, you will be responsible for the smooth operation of our clinical trials service, including workload management and procedure implementation. Main...

  • Clinical Project Manager

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job SummaryWe are seeking an experienced Clinical Trial Manager to support our clinical trial operations team at Bicycle Therapeutics. As a Clinical Trial Manager, you will be responsible for the planning, implementation, and oversight of our clinical trials. This role will involve leading cross-functional teams, managing vendor relationships, and ensuring...

  • Senior Clinical Trials Coordinator

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Cambridge University Hospital NHS Foundation Trust Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Clinical Trials Coordinator to join our team at Cambridge University Hospitals NHS Foundation Trust. The successful candidate will be responsible for managing a portfolio of local and national cancer clinical trials, contributing to cancer research and ensuring the highest standards of...

  • Senior Clinical Trials Coordinator

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Cambridge University Hospital NHS Foundation Trust Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Clinical Trials Coordinator to join our team at Cambridge University Hospitals NHS Foundation Trust. The successful candidate will be responsible for managing a portfolio of local and national cancer clinical trials, contributing to cancer research and ensuring high-quality research is...

  • Specialty Doctor in Clinical Trials

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Cambridge University Hospitals NHS Foundation Trust Full time

    Clinical Trials Medical Specialist Job Summary We are seeking a Clinical Trials Medical Specialist to join our team at Cambridge University Hospitals NHS Foundation Trust. The successful candidate will be responsible for conducting clinical trials in oral and maxillofacial surgery, working closely with our team of specialists to ensure the highest...

  • Pharmacy Clinical Trials Coordinator

    2 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Cambridge University Hospital NHS Foundation Trust Full time

    Job SummaryWe are excited to announce a dynamic new position that will be essential in managing the financial and operational aspects of our extensive pharmacy clinical trials portfolio. Our dedicated and collaborative pharmacy clinical trials team is currently supporting over 300 studies, making this an extraordinary opportunity to be part of a thriving and...

  • Senior Clinical Sciences Trial Leader

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Novartis Full time

    Senior Clinical Sciences Trial LeaderWe are seeking a highly skilled Senior Clinical Sciences Trial Leader to join our team at Novartis. As a key member of our Clinical Sciences and Innovation group, you will play a critical role in planning and executing early phase trials worldwide.Your responsibilities will include:Operationally and scientifically leading...