Translational Research operation manager
Translational research implementation in the company's trials and research projects
- Participates in the practical development and implementation of the TR part of protocol, being the interface between TR and clinical operation management.
- Provides advice to clinical operation managers on how to set up biobanking and TR procedures in the protocol (tissue processing, sending, collection, storing). Participate in the HBM expert team.
- Assess the quality of samples and molecular analysis in the company's projects and clinical trials, and propose solutions when problems occur.
- Works on developing and maintaining a database for TR projects to enable tracking of the TR portfolio of the company, in conjunction with other units at the company's HQ.
- Provides advice to data managers on the design of sample collection forms (sample CRFs).
- Work with the operational department to monitor any deviation in quality of samples or sample workflow. Assess the root cause of the problem and coordinate with the Compliance and Audit department if necessary.
- Support the company's Compliance and Audit department with monitoring and audit of central labs and biobank and if necessary the clinical sites
- Perform vendor assessment for new TR vendors
- Develop and maintain the vendor list for TR, with the TR scientists.
- Develop and maintain the library of HBM guidelines.
- Manage the portfolio of small projects using the company's human biological material for translational research.
- Relevant clinical or biomedical MSc/BSc with at least 4 years of relevant experience (preferentially working in a lab with clinical samples)
- Relevant experience can be any technical role in clinical trials, or applied research in academic, hospital or industry setting, in particular in running biomarker-driven assays (NGS, IHC,etc.). Knowledge in practical implementation of molecular biology assays is a plus.
- High level of proficiency in the use of standard softwares and ability to quickly learn and utilize computer programs as needed
- Credibility in scientific environments
- Dynamic self-starter
- Able to work independently and manage competing priorities
- Well organized and flexible
- Able to function well in a team, whether motivating collaborators and colleagues to move projects forward or providing support to ongoing collaborations
- Able to write and check content and quality of scientific documents
- Good communicator with a broad range of stakeholders
- Excellent spoken and written English