Scientific Liaison
il y a 1 mois
As Scientific Liaison, you are the scientific operational intermediate between our Global Clinical Operations and Logistics department and our network of partner laboratories. You are the primary point of contact for scientific operational follow-up related to lab tests.
Your excellent organizational skills allow you to easily switch between i) providing daily operational support, ii) working on scientific projects, and iii) maintaining an overview on lab-specific issues (e.g. way of working, quality system, validation status, etc). Your hands-on mentality and solid scientific background allow you to confidently provide customer-oriented support.
**Responsibilities and Tasks**:
**Laboratory specific responsibilities**
- Being the point of contact between Cerba Research and the partner/subcontractor labs for scientific operational follow-up.
- Manage lab changes by liaising with internal stakeholders to guarantee continuation of our services.
- Upon award, you work closely with the sponsor and advise in defining the scope of validation as fit-for-purpose.
- Improve the daily working relationships with our partner laboratories by acquiring an in-depth knowledge of their way of working, quality system, testing capabilities, etc.
- Create and maintain relationships with our partner labs by informing them on pipeline projects, understand their main way of working, follow up on test validations, etc. This while communicating progress to relevant internal stakeholders.
**Internal scientific responsibilities**
- Address internal scientific questions (e.g. feasibility requests, questions regarding instruments and reagents, operational follow-up related to reporting and deviations, etc.) from various internal stakeholders (e.g. project management, sales, sample handling, etc)
- Review and issuance of scientific material used by other internal departments
- Assist operational teams during set up of clinical trials and provide checks, when needed, before results can be released
- QA assistance during audits, lab related deviation or issuance and follow-up of CAPA’s
- Prepare and provide ad hoc scientific trainings for our internal departments
- Prepare and issue policies, procedures and working instructions to ensure documentation and optimization of operational flow
- You provide training and development opportunities for team members to enhance their skills and knowledge, ensuring they are equipped to meet project requirements.
- You stay abreast of relevant regulations and guidelines governing scientific research and ensure compliance throughout all operational activities.
- You implement and maintain local quality assurance processes to adhere to local and international regulations.
- Compliance with the Cerba Research Policies, Standard Operating Procedures, Work Instructions and other procedural documents relevant to the role.
- Other tasks as defined by the Head of Department (HOD) necessary to complete the role.
**YOUR BACKGROUND**
- A PhD or Masters degree in a scientific field such as biology, chemistry, pharmacology, or a related discipline is required.
- Scientific Knowledge: In-depth understanding of lab principles and research methodologies relevant to the services provided by Cerba Research, such as clinical trials, laboratory testing, pathology, validation processes, etc.
- Experience with managing scientific projects within the pharmaceutical sector (e.g. clinical research setting, CDMO, etc.) is an absolute must, i.e. ability to lead meetings and maintain project oversight
- Experience within the CRO industry and/or clinical trials and/or broad background in working with partner labs providing a wide variety of lab services is a plus.
- Familiar with regulatory requirements and guidelines governing clinical research and drug development processes, such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and relevant regulatory authorities (FDA, EMA, etc.).
- Familiar with clinical assay validations and clinical laboratory practices
- Strong sense of autonomy
- Excellent verbal and written communication skills combined with honed people skills are essential for interacting with multiple stakeholders in complex projects. Strong organizational skills.
- Quality oriented is an absolute must, i.e. eye for detail. A solid understanding of Quality Control / Quality Assurance is a plus
- Flexible and with good sense of urgency to discriminate between nice-to-haves and need-to-haves in order to ensure business continuity
- Strong scientific assimilation skills, i.e. able to translate complex scientific concepts and techniques into understandable language for internal and external customers
- Customer Focus: A strong commitment to meeting customer needs and ensuring high-quality service delivery, as Cerba Research relies heavily on maintaining positive relationships with clients.
- You strive for continuous improvement by identifying opportunities to streamline processes, improve efficiency,
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