Ref #: 29656

Employment type: Permanent - Full-Time

Location: Spain

Posted: 03-Jun-2021

Description

Role and responsibilities:
• Drives processes and technical frameworks to improve and implement annotation of biosamples from sponsor clinical studies stored at long-term biorepository
• Develops, reviews and maintains biobank related quality documents, oversight-plans, specifications, reports etc, related to biosample annotation to ensure agreement with legal requirements, regulations and Corporate processes
• Connects with internal stakeholders globally such as scientists from therapeutic development units, translational medicine, bioinformatics, clinical data management, data standards and data analysts to gather, discuss and consolidate feedback on biosample annotation content and processes.
• Understands the needs of biosample characteristics an applies experience in project management to successfully run biosample annotation projects.
• Successfully applies knowledge on quality frameworks and regulations such as Good Clinical Practice (GCP), Biobanking related guidelines and practices considering ELSI (Ethical Legal and Social Implications) frameworks, ISO standards and ISBER practices
• Develops, implements and maintains systems and processes to integrate annotation of patient samples hosted at the biobank
• Develops, uses and maintains relevant systems and platforms for biosample information related to the biobank
• Efficiently communicates and manages the global interfaces to internal partners, such as experts / scientists from clinical development, translational medicine and the therapeutic areas in order to establish and raise awareness of biosample annotation on a global company level
• Plans and coordinates meetings, workshops and training sessions on biosample annotation as related to banked samples.

What is Required:
• MS degree or PhD in biomedicine related discipline (life-sciences, biology, biochemistry, biophysics, bioinformatics etc.)
• Solid in spoken and written English.
• 3 – 5 years in working with pharma industry (ideally in clinical development Strong Biology background is of advantage (e.g. cell biology, protein, molecular, etc.)
• 2+ years in leading / conducting projects in relevant industries (pharma, biotechnology)
• Expert knowledge of biobanking and relevant practices
• Proven experience in clinical data management, ETL, databases
• Experience in project management (planning/ tracking via MS project), is preferable
• Strong understanding of clinical drug development strategies
• Strong understanding of the operational considerations in executing biomarker strategies in clinical development is required.

What is Offered:
We offer a permanent contract, full time role based in Madrid or Barcelona. Other locations is Spain can be considered.

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Why join the DOCS team at ICON?

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