We are looking for a highly motivated specialist to join our function for the outsourcing of biomarker projects. You will be part of a team that organizes and monitors biomarker studies on behalf of a sponsor conducted at CROs according to current regulatory guidance’s. As a Biomics Manager you will be responsible for:
- The organization, coordination and monitoring of genomics and biomarker analysis at CROs in support of development projects.
- Data transfer from CROs to internal databases.
- Timely provision of deliverables and adherence to strict project deadlines.
- Regulatory compliance of all conducted work, including documentation.
Key Duties and Responsibilities:
- Engage with CROs/Laboratory services organizations via weekly calls to monitor progress and maintain oversight of agreed outsourced bio-analytical activities.
- Track RFP documentation progress and content both internally to client and externally with selected bio-analytical CROs.
- Monitor and respond to correspondence from various internal functional/stakeholder groups involved in clinical sample analysis and data processing. These will include the client CRO facing sample managers, bio-marker scientists, data acquisition function and sample repository representatives.
- Update and maintain activity tracking spreadsheets, including budget planning and forecasting, and communication plans.
- Assist with the further development of spreadsheets for activity and stakeholder tracking within the SMART sheet environment.
- Uploading and verification of bio-analytical data generated by CROs to client data servers.
- Track and quantify problems with data upload, sample suitability and integrity.
- Interpret study protocols to create request for clinical biomarker analysis and contribute to and review assay validation reports.
- Contribute to ongoing development of A4P products and services.
Who you are:
You have completed your MSc or equivalent studies in Biology, bioanalysis, genomics. Ideally, you have experience in bioanalytical work for genomics or large molecules including immunogenicity testing.
Your English is excellent, both written and spoken. You are familiar with standard office software, Google Drive and gMail. Your strengths are attention to detail, dedication, flexibility, communication and teamwork. You are extremely well organized and can manage a high degree of multitasking and parallel workstreams. You are able to follow directions and pro-actively ask questions when needed.
Genomics and Biological/bioanalytical expertise and experience with databases and project management tools (e.g. SMART sheets) are of benefit.
The position would be located at the main office in Sandwich, Kent although working from home with expensed travel to the office weekly / biweekly is open for consideration. The role will involve some limited European travel, once or twice per year.
Further information about the role can be obtained by from Laura Blockley (firstname.lastname@example.org, +44 7741637999)