Clinical Study Manager

This is an exciting time at ANGLE and our team in Guildford are looking for a Clinical Study Manager to oversee the planning, design, initiation, progress and conduct of clinical studies in Europe.

The Clinical Study Manager (CSM) Europe will have responsibility 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 Chief Scientific Officer with a dotted line to Director of Regulatory Affairs.

At ANGLE, we foster a dynamic, entrepreneurial approach to translating leading-edge translational research into clinical diagnostics. 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 describe your background and what you can bring to our team along with attaching your resume.

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 including study results / study data.


• Provide in-depth evaluation(s) of study data, including statistical analyses of results obtained, to assess study results, outcomes and findings.


• 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.


• Undertake additional ad-hoc tasks as required
  
  Bachelors degree in nursing, biological sciences, or equivalent experience required. An advanced, relevant degree (MSc or PhD) would be desirable.


• Proven experience in clinical research within a medical device, pharmaceutical, biotechnology, CRO, and/or healthcare setting.


• Proven 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.


• Working knowledge of clinical study design and biostatistics and/or bioinformatics is essential.


• Experience in writing clinical study procedures and other clinical documents is essential.


• Experience working with Institutional Review Boards and/or Ethics Committees to secure clinical study protocol approvals is highly desirable.


• Highly proficient with Microsoft Office Word and Excel. An eye for detail and commitment to high-quality data


• 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.


• Entrepreneurial thinking and work ethic.


• A flexible, can-do approach to the requirements of the job.
  
  ANGLE is a world-leading liquid biopsy company commercialising a patent protected platform technology that can capture rare circulating tumour cells (CTCs) from blood, in a minimally invasive way, for downstream analysis.


ANGLE's Parsortix® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood. Parsortix technology comprises a microfluidic device that captures CTCs from blood based on their size and compressibility. CTCs are cancer cells that have detached from the primary tumour and entered the blood circulation, and they play a critical role in initiating metastasis. Once harvested, the CTCs can be comprehensively analysed to provide a wealth of information about the patients tumour, advancing cancer research and potentially personalized medicine. This technology has the potential to deliver profound improvements in clinical and health economic outcomes.

ANGLE has established a CTC harvest and analysis service from our UK-based Clinical Laboratory based in Guildford for customers worldwide. In alignment with company priorities, we plan to rapidly expand our services to include molecular profiling of CTCs and ctDNA using digital PCR and NGS to add to our image-based assays.

As a member of our highly skilled team, you will receive opportunities for training and development and a competitive benefits package.