CK Group are recruiting for a Bioanalytical Study Monitor to join a leading drug discovery business, at their state-of-the-art facilities located in Slough on an initial 12 month contract. The Company:
Our client is in the business of improving the lives of patients around the globe with a particular focus on neurology and immunology-based diseases. Location:
This position can be based on our client’s site in Slough or remote working.Bioanalytical Study Monitor Role:
- Interact with bioanalytical project representatives to execute the bioanalytical strategy, including performing method transfer/validation and bioanalysis.
- Oversee (neutralizing) immunogenicity method development and validation.
- Collaborate with multiple internal and external stakeholders.
- Participate in clinical study setup and documentation.
- Participate in writing of the Immunogenicity Risk Assessment or other submission documents.
- Participate in harmonisation of bioanalytical testing and reporting processes.
- Experience in the pharma or CRO industry supporting regulatory bioanalysis of large molecules.
- Knowledge of a range of bioanalytical techniques mainly (neutralizing) immunogenicity assays, biomarker assays and ligand binding assays.
- Knowledge of the latest regulatory standards required for GXP studies.
- Previous experience managing contract research organisations.
- Proficient in study planning and oversight.
- Experience with working on process change management.
For more information or to apply for this Bioanalytical Study Monitor position, please contact Science Contracts Team on 0191 3848906 or email email@example.com, quoting job ref 51207.
It is essential that applicants hold entitlement to work in the UK.