- Project management of GLP and GCP clinical studies
- Technical specialism in Bioanalytical techniques
- Expertise in overseeing Pharmacokinetic, Immunoassay and Biomarker validations
- IT literacy and numeracy skills with the knowledge of calculating and tabulating results
- Good interpersonal skills with the ability to network and build close relationships in order to collaborate with both Clients and members of the business in order to ensure that the business TQA promise is consistently met.
- Scientific background to 1st Degree level and knowledge within a defined area(s) with good project management skills.
- Good experience of preparing documents with technical support or guidance across multiple projects.
- Good working knowledge of the Chemical and Pharmaceutical Industry with good commercial understanding and natural business acumen.
- Overall responsibility for the scientific, administrative and regulatory conduct of GLP and GCP studies in a GxP regulated laboratory
- Good technical understanding of a range of analytical techniques including Bioanalytical and Immunoassay Techniques
- Overseeing Pharmacokinetic, Immunogenicity and Biomarker validation studies in accordance with regulatory guidance.
- Preserving data integrity ensuring all data are accurately and fully documented following ALCOA plus principles and computerised systems are validated and fit for use in the study
- Recording and resolution of deviations impacting study conduct
- Ability to produce high quality reports, as a complete, true and accurate record of study conduct and conclusions
- Effective and enthusiastic communication with customers from a range of industries.
- Understanding of capabilities of other teams within the business and wider C&P environment.
- Skilled project management, including ability to generate / edit multi-technique reports.
- Able to define projects customer requirements, manage and deliver multi-technique projects.
- Ability to manage and report projects, drawing on findings from several techniques with technical support to solve customer problems.
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GLP/GCP Bioanalytical Study Director Lancashire, England, United Kingdom Posted on 11/21/2023 B - Intertek Group Plc
Description
Due to growth, we have an exciting opportunity to grow our Bioanalytical Team with a new Study Director. you will demonstrate good interpersonal skills with the ability to network and build close relationships in order to collaborate with both Clients and members of the business in order to ensure that the business TQA promise is consistently met.
Coming from a scientific background to Degree level and knowledge within a defined area(s) with good project management skills.
We need you to have:
ABOUT THE OPPORTUNITY
This role will provide the opportunity to work as a member of the Laboratory with accountability for leading, managing and driving the TQA promise. You will demonstrate your skillset within a technical area as well as project management skills and have the confidence to provide information and background on specific programmes of work to both Colleagues and Clients.
You will be accountable for being the Project Manager for both existing and developing Clients and you will have good communications skills and the ability to converse with key contacts, providing them with accurate information and progress reports on a consistent basis.
WHAT WE OFFER
Join Intertek and become part of our global network of inspiring and entrepreneurial colleagues. We are a global family that values diversity and we thrive working together with precision, pace and passion. We are working to make the world Ever Better, ensuring the quality, safety and sustainability of products and services used by millions of people around the world.
Competitive salary/benefits
Development and career opportunities around the Globe
Working in a highly motivated team and dynamic working environment
In this opportunity you'll be joining our Bioanalytical Immunoassay team, based at Intertek Pharmaceutical Services Manchester (IPSM), Blackley Manchester
We are an Equal Opportunity Employer who do not discriminate against applicants. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex or national origin.
Intertek operates a preferred supplier arrangement and we do not accept unsolicited approaches from agencie s.
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