- The clinical scientist/manager is leading and coordinating clinical validation evidence development at both local and international sites, as part of product development projects, for CE-IVD as well as US registrations.
- The clinical scientist/manager outlines the clinical evidence strategy, in collaboration with the multifunctional project teams. Serves as a core team member of the IVD development team, providing scientific expertise and lead the execution of clinical evidence studies to ensure on time delivery of clinical development deliverables.
- The clinical scientist/manager supports development of the scientific validity dossier, feasibility studies. Supports in providing answers for clinical related topics in audits and regulator questions.
- The clinical scientist/manager supports in establishing efficiency improvements in the context of clinical development.
- Designs the clinical development strategy in conjunction with the project team.
- Prepares clinical design validation plans that meet product design goals, regulatory requirements, and company procedures.
- Manages within projects all clinical validation activities, to ensure on time delivery, including all aspects of contracted clinical service provider. Prepares clinical performance study protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies.
- Negotiates all aspects of clinical performance study agreements.
- Proposes and negotiates budgets for clinical performance studies. Initiates payments to clinical sites and manages study budgets.
- Closely collaborate with statistics to ensure relevant study designs and analysis of study data.
- Identifies and qualifies study investigators and sites.
- Conducts pre-study, initiation, monitoring, and close-out site visits and completes site visit reports.
- Ensures site compliance with clinical performance study protocol and ICH/GCP Guidelines; assures subject rights, safety, and welfare are protected.
- Ensures data integrity through completeness, accuracy, and legibility.
- Actively participates as member of cross-functional project teams, ensures cohesion between analytical and clinical activities, and lends support as needed across to overall validation activities.
- Participates in assessing performance data generated by cross-functional teams.
- Collaborates in development of the scientific validity dossier.
- Reviews data, prepares, and presents clinical data reviews and summaries.
- Responds to audit, requests from the regulator, and data queries.
- Functions independently in the field and interacts with all levels of medical and scientific professionals.
- Supports in optimizing clinical study documentation and processes according to overall IVD standards.
- Travel percentage of 10% (US)
Requested competences and skills:
PhD or masterâs degree in a scientific field (preferred) of study with 2-3+ years of relevant experience working in clinical operations, pharmaceutical/ biotech industry/medical device and/or a CRO. CRA experience preferred.
- Experience with trial master file organization, regulatory documents, inspection preparation/readiness (site and sponsor) and all aspects of trial and vendor management.
- This position requires understanding of:
- Clinical laboratory
- Assay/instrument principles involving in vitro diagnostic product design and usage
- Project management
- Scientific, statistical, regulatory and compliance requirements of clinical research
- High degree of competence in clinical research and experience in all aspects of a clinical research program.
- Strong practical knowledge of compliance and regulatory environments (EU, US is an asset).
Specific professional knowledge:
- Scientific and technology background in molecular diagnostics.
- Strong working knowledge of GCP and IHC guidelines, applicable to diagnostics.
- Experience in organising and executing clinical studies for regulatory submissions.
- Strong communication and listening skills
- Proactive attitude
- Excellent interpersonal and team working skills
- Significant degree of autonomy
- Collaborative problem solver, handles conflict constructively
- Excellent technical writing and documentation skills
- Well-developed organization, planning and prioritization skills to meet budget and time line expectations
- Able to work under pressure and have a flexible approach
- Diplomatic and able to maintain secrecy concerning strictly confidential information
- Quality minded with attention to detail
- Willing to travel frequently – internationally
- Fluency in English and Dutch, any other language is considered an asset
- PC skills: Microsoft Office, eDC systems is an asset