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PGYWn
Medical & Life Sciences
Permanent
CLINICAL TRIAL TECHNICAL MANAGER
BASED BELLSHILL/HYBRID SALARY £50-60,000 DOE PLUS EXCELLENT BENEFITS
Headquartered in Bellshill, ESS Recruit’s client is at the forefront of new modern medicinal product development. Their focus is to establish a lead product as a platform in multiple different disease areas and establish end-to-end fully integrated capabilities to manufacture the product at scale. These products will revolutionise how we treat some very serious and in many cases, almost untreatable medical conditions. The business has one product currently at Phase II of a clinical trial, with another trial due to start and a plethora of potential trial applications to follow. They now need to hire a Clinical Trial Technical Manager.
Reporting to the Senior Director of Clinical Operations, the Clinical Trial Technical Manager will join a small but growing team and you will play a key role leading the science, handling, delivery and clinical trial strategy for both in-house operations and with outsourced vendors. The client has retained a large amount of inhouse laboratory trial work where your microbiology and lab management skills will help ensure planning and execution, sample handling, management and bioanalysis follow MHRA and agreed trial guidelines. Externally, you will oversee CRO activity and processes along with sample shipping and test. Other key responsibilities will include:
The successful candidate is educated to degree calibre minimum in a scientific (ideally biology or microbiology) discipline. It is likely you have come from a pharmaceutical or biotechnology product development research/laboratory background. Candidates will have proven experience of bio/pharma clinical trial operations or laboratory/product research, including strong knowledge of the laboratory processes, drug or sample management, GCP/GLP and other applicable regulatory requirements. We would be very keen to hear from candidates with any clinical trial, research or lab work in and around gene sequencing, microbiome/biota, short chain fatty acids, bile acids and cytokines and those involved in the development of bioanalytical strategies.
This role represents an incredible opportunity for a highly experienced Laboratory Manager, Research Scientist or technical Clinical Trials Manager to take control of the function and grow the capability along with your career. You are also motivated by the chance to work on completely novel modern medicine product development. An excellent base salary of £50-60,000 DOE is supplemented by share options, company bonus, private health care, pension and 33 days leave.
There is flexibility around hybrid working and we may even be open to part-time remote options with some travel to site.
To apply to this role please contact our recruitment partner Bruce Hydes at ESS Recruit.
BASED BELLSHILL/HYBRID SALARY £50-60,000 DOE PLUS EXCELLENT BENEFITS
Headquartered in Bellshill, ESS Recruit’s client is at the forefront of new modern medicinal product development. Their focus is to establish a lead product as a platform in multiple different disease areas and establish end-to-end fully integrated capabilities to manufacture the product at scale. These products will revolutionise how we treat some very serious and in many cases, almost untreatable medical conditions. The business has one product currently at Phase II of a clinical trial, with another trial due to start and a plethora of potential trial applications to follow. They now need to hire a Clinical Trial Technical Manager.
Reporting to the Senior Director of Clinical Operations, the Clinical Trial Technical Manager will join a small but growing team and you will play a key role leading the science, handling, delivery and clinical trial strategy for both in-house operations and with outsourced vendors. The client has retained a large amount of inhouse laboratory trial work where your microbiology and lab management skills will help ensure planning and execution, sample handling, management and bioanalysis follow MHRA and agreed trial guidelines. Externally, you will oversee CRO activity and processes along with sample shipping and test. Other key responsibilities will include:
- Co-ordinating the design, implementation, and management of the technical and analytical aspects of clinical trial(s) across multiple participating hospital sites, ensuring timely sample and data collection and Good Clinical Practice (GCP) compliance.
- Providing clear guidance to investigators in relation to clinical specimen collection, process, storage, and handling.
- Identifying and working with vendors to deliver bioanalytical services in support of ongoing clinical development programs.
- Liaising with bioanalytical providers to develop protocols and oversee activities to ensure data is reported accurately and in a timely manner for the responsible program.
- Managing the co-ordination and oversight of the shipment of clinical trial samples and other supplies between our business, clinical sites and sample storage facilities.
- Provide subject matter expertise in microbiology and scientific activities in relation to clinical development.
- Development, maintenance and updates of technical and analytical study documentation and associated materials with the appropriate version controls.
- Providing supervision of more junior members of Clinical Operations staff, as required.
- Work closely with the research and analytical teams to ensure clinical milestones are achieved and to ensure issues and obstacles are mitigated and managed accordingly.
- Review trial data and procedures ensuring good quality data.
- Contribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents.
The successful candidate is educated to degree calibre minimum in a scientific (ideally biology or microbiology) discipline. It is likely you have come from a pharmaceutical or biotechnology product development research/laboratory background. Candidates will have proven experience of bio/pharma clinical trial operations or laboratory/product research, including strong knowledge of the laboratory processes, drug or sample management, GCP/GLP and other applicable regulatory requirements. We would be very keen to hear from candidates with any clinical trial, research or lab work in and around gene sequencing, microbiome/biota, short chain fatty acids, bile acids and cytokines and those involved in the development of bioanalytical strategies.
This role represents an incredible opportunity for a highly experienced Laboratory Manager, Research Scientist or technical Clinical Trials Manager to take control of the function and grow the capability along with your career. You are also motivated by the chance to work on completely novel modern medicine product development. An excellent base salary of £50-60,000 DOE is supplemented by share options, company bonus, private health care, pension and 33 days leave.
There is flexibility around hybrid working and we may even be open to part-time remote options with some travel to site.
To apply to this role please contact our recruitment partner Bruce Hydes at ESS Recruit.
