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Study Manager - Small Molecule Bioanalysis
- Posted 24 March 2023
- LocationYork
- Job type Permanent
- Discipline Research & Development
- Reference83221
- Contact NameGreg Hammond
Job description
BioTalent have begun working on an exciting new Study Director opportunity who will be part of an exceptionally talented Small Molecule Bioanalytical Services team based in York, UK.
This is a chance to be working with a leading organisation who specialise in Regulatory Submissions, Preclinical Studies and Clinical Trials for clients who are striving to develop and deliver lifesaving drug applications.
You will be responsible for:
You will bring the following:
If you would like to learn more about this unique opportunity or to recommend a valued professional from your network, you can reach out using the contacts below!
lewis.besbeech@biotalent.com // +44 (0)2033438780
BioTalent Ltd are acting as an employment agency in relation to this opportunity.
This is a chance to be working with a leading organisation who specialise in Regulatory Submissions, Preclinical Studies and Clinical Trials for clients who are striving to develop and deliver lifesaving drug applications.
You will be responsible for:
- Adhering to company SOPs and ensuring all activities are meeting the relevant regulatory standards and biological/chemical safety regulations (COSHH).
- Continuous maintenance of your team training files, making sure their work is conducted in compliance with level of training received and SOPs in place.
- Learning/operating company computer systems, policies and associate software to champion your requisite duties.
- Supporting management in the overall day to day operations of your department (leading problem-solving activities relating to Quality and overall process improvements)
- Managing all liaison activities between sponsors, clients and internal teams.
- Championing generation of study protocols, data transfer agreements and analytical reports.
- Deploying work schedules for lab scientists and upskilling in the scientific methodology involved in bioanalysis of small molecules (sample management, batch preparation, data analysis).
- Management of data checking/Quality Control review, construction and submission of result tables, Quality investigations, CAPA system management and financial monitoring.
- Contributing to business development, continuous improvement, staffing levels, workload and process management decisions with senior management.
- Understanding and be capable of carrying out PK/TK and method validation/sample analysis studies.
- Troubleshooting support of analytical equipment, use/maintenance proficiency of said instrumentation and related software.
- Oversee and coordinate method development for novel analytical methods.
You will bring the following:
- 3+ years of study management experience in clinical and/or preclinical studies.
- Strong background knowledge of small molecule analysis in support of PK and PD studies.
- Experience working in a regulatory environment, managing studies that are compliant with GLP/GCP.
- Experience in a client facing role with the ability to provide high level advice and guidance to clients.
- Non-Smoker: due to the nature of some of the testing carried out in the laboratory.
If you would like to learn more about this unique opportunity or to recommend a valued professional from your network, you can reach out using the contacts below!
lewis.besbeech@biotalent.com // +44 (0)2033438780
BioTalent Ltd are acting as an employment agency in relation to this opportunity.
