We are looking for you!
Mimark is seeking a person responsible for the operational management of biological samples and associated clinical activities, ensuring the efficient coordination of sample logistics, associated clinical data and documentation of the biobanking processes, for the proper development of clinical studies under ethical, regulatory and quality standards.
The position combines biobank operations, laboratory activities, and clinical studies site coordination and management to ensure the successful execution of clinical investigational and validation studies, as part of the clinical development activities in Mimark.
Responsibilities
General
- Reporting to Clinical Lead
- Active participation in Area and company-wide meetings
- Continuous follow-up of activities, KPIs and reporting
- Ensure proper biobank and clinical data organization and record management
- Respect company policies and procedures
- Maintain a safe and regulatory-compliant work environment in accordance with the Quality Management System (ISO13485)
- Understand and identify non-conformities related to biobank and clinical activities, and provide technical support for CAPA implementation when required, in coordination with QA.
- Promote company values and a positive working environment
- Collaborate cross-functionally to achieve company objectives
Biobank Operations
- Coordinate shipment of collection kits and biological sample logistics between clinical sites and logistics’ provider
- Manage reception, labeling, processing, registration, storage and traceability of biological samples according to approved SOPs
- Ensure biological sample and associated data registration within biobank databases
- Oversee sample inventory control and storage conditions
- Coordinate sample retrieval and shipment for internal and external projects
- Support the implementation and maintenance of biobank quality management system
- Prepare and support internal and external audits related to biobank processes
- Ensure compliance with applicable regulations regarding human biological samples and data protection
- Supervise laboratory stock management and consumables inventory
Clinical Operations
- Provide support to study implementation internally and with external partners, CROs and recruiting sites
- Coordinate clinical operations for investigational studies, including site feasibility, site initiation, study monitoring, and site closing
- Coordinate clinical operations for clinical-regulatory studies with participating CRO
- Provide support to review and maintenance of study documentation and Trial Master File documentation, when applicable
Any other issue that may be delegated by its supervisor and that fits into the competencies of the job description.
Requirements
We are looking for a candidate with the following qualifications, skills, and qualities:
- Bachelor or CFGS in science, or similar
- Biobank management experience, including managing human biological samples and associated databases (required)
- Experience in clinical investigational and / or regulatory studies
- Fluency In English (as we aim to recruit in EU and US countries)
- Budget management experience
- Proficient in project management and entrepreneurial spirit
- Strong planning and coordination skills
- Problem-solving capability
- Quality-focused mindset
- Strong documentation and traceability practices
- Excellent communication and stakeholder management skills
- Passionate, well-organized, proactive, and committed