Clinical Study Manager

Guildford, UK

ANGLE is a world-leading liquid biopsy company with offices in Guildford (UK), Toronto (Canada) and Philadelphia (US).  ANGLE’s proven patent protected liquid biopsy platform products have the potential to be used in cancer diagnostics to enable early, accurate identification of an individual’s condition for the prevention, treatment, and monitoring of disease.

With 1 in 2 UK people being diagnosed with cancer in their lifetime*, ANGLE’s liquid biopsy technologies have the potential to help clinicians select the most appropriate drugs and therapies for an individual patient.  As such, our technologies support the development of Precision Medicine.

In 2021 we opened GCLP compliant clinical laboratories in Guildford (UK) and Philadelphia (USA) to provide “pharma services” for cancer drug trials and, once the labs are accredited, laboratory developed tests (LDTs) for patient management.  The pharma services business offers dynamic analysis of patient condition before, during and after the patient receives the drug, assessing both CTCs and CTC clusters recovered from a simple blood test.  We are also pursuing an FDA product clearance for the Parsortix system and have submitted a full De Novo submission, which is currently in substantive review with FDA.

*Source: Cancer – NHS (www.nhs.uk)

This is an exciting time at ANGLE and our team in Guildford, UK are looking for a Clinical Study Manager – Europe specialising in planning and managing clinical studies. 

This is an important position and the Clinical Study Manager (CSM) – Europe will have responsibility to work with the Associate Commercial Director and the Clinical Studies Director to oversee the planning, design, initiation, progress and conduct of clinical studies in Europe and will be the main contact to internal and external parties involved in the studies.  The CSM-Europe will ensure strict compliance to applicable laws and regulations, including ICH, GCP, FDA, EU MDR and IVDR, GDPR, etc.  In addition, the CSM-Europe will manage relationships with KOLs and other external parties involved in the clinical studies and other partnerships.  This position will report to the Associate Commercial Director with a dotted line to the Clinical Studies Director.

Principal Accountabilities:

  • Development of specific study aims and goals to support wider ANGLE strategic, commercial and technical objectives.
  • Manage and organise all aspects of a clinical study from design and set-up through close-out.
  • Write/prepare study protocols and related subject information and consent forms, study/site specific SOPs, case report forms, monitoring reports, study reports, etc.
  • Prepare study site and laboratory site notebooks and ensure materials are kept up to date.
  • Train study and laboratory personnel on conduct of studies, including enrolment requirements, data collection and management, and specimen collection and management.
  • Ensure study specific equipment is appropriately identified, procured, installed and qualified at study sites to support training, initiation and delivery activities.
  • Tracking of study specific materials to ensure appropriate supply of required materials is maintained at study sites and/or laboratories.
  • Track and monitor status, progress, budgets and timelines of clinical studies and provide updates to the study team and senior management in a timely manner.
  • Prepare and/or review documents needed for submission to ethics and regulatory bodies.
  • Ensure compliance with all applicable company and local/regional/international regulatory requirements (e.g. ICH, GCP, GCLP, EU MDR and IVDR, EU Privacy and Data Protection Regulations (GDPR), HIPPA, FDA, US CFR 21, etc.).
  • Participate in site identification/selection and management of relationships with site investigators, physicians, research staff and external consultants, including contract and budget negotiations.
  • Visit trial sites as required (e.g. for qualification, initiation and training, monitoring, etc.), write and/or review monitoring visit letters and reports, and ensure follow-up of any issues identified at sites.
  • Collect, track and maintain all required study-related documentation.   
  • Manage relationships with vendors (e.g. CRO or independent clinical service providers), including identification of partners, development of contracts, etc. 
  • Manage and foster positive and long-lasting relationships with KOLs. 

Qualifications, Experience, Knowledge and Attributes:

  • Bachelor’s degree in nursing, biological sciences, or equivalent experience required.  An advanced, relevant degree (MSc or PhD) would be desirable.
  • Demonstrable experience in clinical research within a medical device, pharmaceutical, biotechnology, CRO, and/or healthcare setting. 
  • Experience in the oncology space either in a research capacity or with a commercial organisation.
  • Extensive knowledge of clinical study and regulatory requirements (e.g. FDA guidelines and regulations, ICH guidelines, Good Clinical Practices (GCP) governing the conduct of clinical trials, etc.) is essential.
  • Experience in writing clinical study procedures and other clinical documents.
  • Self-directed and able to work independently with little or no direct supervision.
  • Strong interpersonal, verbal and written communication skills; demonstrated English written and oral presentation and communication skills – experience in delivering complex technical, clinical based written communication materials is essential.
  • Ability to form strong and constructive internal as well as external professional relationships.
  • Ability to cope under pressure and meet tight and last-minute deadlines. 
  • Problem-solving and detail oriented organisational skills.
  • An eye for detail and commitment to high quality data
  • Continuous learner with a keen appetite for cross-disciplinary work
  • A flexible, can-do approach to the requirements of the job
  • Entrepreneurial thinking and work ethic
  • Experience working with Institutional Review Boards and/or Ethics Committees to secure clinical study protocol approvals is highly desirable.
  • Knowledge of biostatistics and experimental design related to clinical studies. 
  • Highly proficient with Microsoft Office Word and Excel.

Join our Team

At ANGLE, we foster a dynamic, entrepreneurial approach to translating leading edge translational research into clinical diagnostics. We offer the potential for significant corporate growth and career development. We promote a culture of collaboration and shared excellence while encouraging an open and honest exchange of ideas.

We are always in search of potential employees who share our vision and want to make a difference today. In your submission, please note the position you are interested in, describe your background and what you can bring to our team along with attaching your resume.

As a member of our excellent and fast-growing team you will receive opportunities for development and a competitive benefits package.

Salary estimate – £ competitive

Please let us know if you require disability-related accommodation during the recruitment process so that we can work with you to meet your needs.

If you submit an application to us, your application and personal details will be processed in accordance with our Data Privacy Notice for Job Candidates.

Important notice to Employment Businesses/ Agencies

ANGLE does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact our ANGLE recruitment team to obtain prior written authorisation before referring any candidates. In the absence of such written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ANGLE. ANGLE shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

 

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