Clinical Scientist
Vor 7 Tagen
The Clinical Scientist is responsible for the technical oversight of laboratory testing in both the daily operations of the laboratory and the efficient and effective delivery of clinical research activities.
This will include clinical validation and clinical utility of laboratory developed tests (LDT) and in vitro-diagnostics (IVD) products.
Position Overview The Clinical Scientist is responsible for the technical oversight of laboratory testing in both the daily operations of the laboratory and the efficient and effective delivery of clinical research activities.
This will include clinical validation and clinical utility of laboratory developed tests (LDT) and in vitro-diagnostics (IVD) products.
RESPONSIBILITIES Include, but are not limited to, the following:
Providing day-to-day supervision of test performance Monitoring test analysis to ensure that acceptable levels of analytic performance are maintained Generating reports and identifying results requiring urgent action as well as advising clinicians on testing Verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including precision and accuracy of each test and test system Contributes to the development of clinical evidence plans for studies related to LDT and IVD medical diagnostic products.
Partnering with other cross-functions to design clinical study concepts and prepare study protocols Collaborate with key opinion leaders (KOLs), biostatisticians, and outside consultants to provide clinical science inputs into clinical evidence plans.
Provide support in preparation for scientific meetings (e.g., advisory boards, consultant meetings, and investigator meetings), regulatory submissions, and labelling documents Collaborate with other functions; including clinical operations, medical affairs, regulatory affairs, research and development (R&D), and commercial/marketing, as needed Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.
Identifying training needs and assuring that each individual performing tests receives regular training and education appropriate for the type and complexity of the laboratory services performed.
Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently.
Contribute to the authoring and revision of regulatory submissions.
Support and comply with the company's Quality Management System policies and procedures Meeting Continuing Professional Development (CPD) requirements applicable to the scope of practice.
ESSENTIAL BACKGROUND/SKILLS Degree in a Scientific discipline (i.e., PhD in Biochemistry, Molecular and Cellular Biology, Clinical Chemistry desired) At least five years' relevant medical laboratory experience.
Proven ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate a number of tasks simultaneously.
Significant experience with scientific projects including development of protocols.
Strong understanding and experience in liquid chromatography mass spectrometry (LC-MS) based testing: background in either lipidomics, lipid chemistry, biochemistry, proteomics and various MS models.
Significant statistical and data analysis experience with data integrity, exploration, analysis and presentation Demonstrated experience, knowledge, expertise and skills within the respective discipline i.e., developing research projects from inception to delivery Sound knowledge of QC/QA, QAP and troubleshooting High attention to detail and experience working in a fast-paced environment.
DESIRABLE QUALIFICATIONS/SKILLS Strong communication skills to convey complex scientific concepts, research findings, and clinical trial results clearly, accurately, and effectively to diverse audiences, including colleagues, regulatory agencies, and stakeholders.
Strong analytical skills to analyse and interpret clinical data, evaluate study outcomes, and generate scientific evidence supporting product development, regulatory submissions, and evidence-based decision-making.
Demonstrate leadership skills to inspire and motivate cross-functional project teams, foster collaboration and teamwork, and drive project success, achieving common goals and delivering high-quality results.
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