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JOB PURPOSE

Works as part of a team to carry out analytical work within the assigned projects to execute activities associated with the conduct of a clinical trial. To lead or support trial activities for one or more trials, with a level of supervision. Helping to develop and validate appropriate test methodology and specifications. This includes the generation of revenue by conducting fee-for-service analyses of biological samples (e.g., blood, saliva, stool, urine, bacteria, etc) for external clients using various equipment (e.g., flow cytometers, centrifuges, incubators, analytical and statistical software, office equipment, etc.).

MAIN AREAS OF RESPONSIBILITY

Laboratory and Scientific Duties

• Assumes the responsibility of study lead for projects and assays. This includes planning day-to-day and study activities for themselves and others, however, consults with Senior/Principal Scientist and/or Manager as needed and also assists with planning the work of others.
• Oversees the work of others (Research Associates/other Scientists) and assists in capacity, reagent planning, and inventory as needed.
• Develops and validates bioanalytical tests to meet the company or client’s needs.
• Clinical sample analysis and clinical sample reporting.
• Reporting of data generated (including presenting to the client).
• Drafts guidance and reports documents for projects (Lab Manuals, Validation Phase Plans, Method Development Plans, Sample Analysis Plans, Sample Analysis Reports etc.).
• Trouble shooting when required, performing literature research and sharing solutions.
• Sharing of knowledge and providing input on training and scientific development of more junior staff.
• Odoo timesheet and planning accurately and efficiently.

Ad-hoc

• Writes and/or reviews/validates standard operating procedures (SOP´s), standard working procedures (SWP´s), documents, forms and spreadsheets.
• Provides training and shares insights regularly.
• Increased involvement in the chasing of revenue and reaching monthly targets.
• Direct communication with a client.
• Assesses systems being used and identifies areas for improvement.
• Equipment management (Custodian) identifies issues with equipment and troubleshoots.
• Assumes the responsibility of study lead on studies.
• Assumes a leadership role in training other staff members in multiple tasks and methods.

QUALIFICATION AND EXPERIENCE

• A minimum level of a Master’s degree (MSc) in a scientific field with 2-3 years experience or 4-5 years of experience in a relevant field of work is required.
• On-going general International Organization for Standardization (ISO), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) awareness and training needs to be provided to all staff. The job holder needs to ensure that he/she is up to date with the available training.
• Previous work experience in a relevant field with expertise in pipette handling, following standard protocols and using basic equipment (e.g., centrifuges, biosafety cabinets, plate washers and incubators).
• The ideal candidate should have prior experience working with analysers e.g., electrochemiluminescence analysers, microplate readers, Flow cytometers etc.
• Working within a good practice (GxP) and/or Good Clinical Laboratory Practice (GCLP) accredited environment.

SKILLS AND COMPETENCIES REQUIRED

• The position requires a detailed orientated approach and the ability to work under pressure.
• Some emotional demands due to deadlines or the fact that it may be required of the job holder to work on special holidays/weekends in order to meet the deadlines and scheduled work of the client/CRO.
• Certain samples to be processed (e.g. saliva, stools, etc) may not be pleasant to handle due to their specific nature.
• On-going general International Organization for Standardization (ISO), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) awareness training needs to be provided to all staff. The job holder needs to ensure that he/she is up to date with the available training.
• On-going professional development is strongly encouraged; this may take the form of sponsor-funded seminars, workshops, society meetings, congresses, etc.
• Good knowledge of written and spoken English
• Proficient in Excel and Microsoft