Key Responsibilities: Manage and coordinate clinical trials related to IVD testing, including patient sampling, clinical test execution, and data collection.
Develops clinical trials strategy to maximize efficiency cost of trails in alignment with product strategy and company objectives.
Oversee clinical trial activities, ensuring compliance with protocols, Good Clinical Practices (GCP), and regulatory standards.
Maintain comprehensive and accurate records of trial activities, including patient records, test results, and trial data.
Coordinate with clinical laboratory teams to ensure accurate and timely testing of samples.
Evaluate and analyze clinical data, providing reports and feedback to stakeholders.
Ensure adherence to Institutional Review Board (IRB) regulations and ethical guidelines throughout the trial process.
Liaise with cross-functional teams including clinical labs, regulatory bodies, and external partners.
Monitor trial progress and report any deviations or issues to senior management.
Provide technical support and guidance to clinical teams regarding laboratory procedures and testing methods.
Qualifications: Bachelors degree in Chemistry, Biology, or a related scientific field (Masters degree preferred).
Minimum of 3-5 years of experience in clinical trials management, with specific experience in IVD testing in clinical laboratory environments.
Strong understanding of clinical trial processes, patient sampling, and laboratory testing methodologies.
Familiarity with IRB submissions, regulatory compliance, and GCP guidelines.
Proficiency in clinical data analysis and evaluation.
Excellent organizational and record-keeping skills.
Strong communication skills and ability to work collaboratively with multidisciplinary teams.
Lab experience and technical proficiency in diagnostic testing methods.
Preferred Skills: Experience working with diagnostic assays and IVD product development.
Familiarity with clinical lab accreditation standards (e.g., CLIA, CAP).
Experience in managing multiple trials simultaneously.