Assist in biomarker related clinical operations (training will be provided) and oversee outsourced biomarker analyses with external CROs. Work closely with clinical operations team/asset development leader/CROs in biomarker sample tracking vs EDC reported information (data reconciliation), consent confirmation/review (if required), setting up/provide input in biomarker analyses workflow e.g., EDC, IRT, ICF, DTS/DRA, CSR, sample labelling, etc.
Aid the design and execute experiments for the development and validation of biomarker assays to be implemented in the clinic. Support writing/review and maintenance related SOPs/WIs/Lab Manuals, assay validation plans and reports or publications, worksheets, summary of QC/data results from assay validation and record in electronic laboratory notebook or preclinical reports.
Perform pharmacodynamic (PD) analyses of clinical samples: PD analyses of clinical samples (e.g., hair follicles and tumour) via RT-qPCR or protein-based methods (mostly Western blot or IHC), including all required documentation for clinical sample analysis in compliance with regulatory requirements. Support in writing/review PD reports.
Develop and perform lab assays with preclinical samples (cell lines and/or tissue/serum from in vivo studies) to determine PK/PD correlations. Join team discussions around planning and design of related in vivo pharmacology studies.
Handling and managing of clinical samples in compliance with HBRA requirements and EDDC internal SOPs. Provide support in internal/external audit preparation, QC all incoming clinical samples to ensure compliance e.g., correct sample labelling, correct sample collection, shipping conditions, accurate requisition forms, etc, work closely with clinical operations team, CRO, and clinical trial sites in clinical sample handling and report any non-compliance found to the clinical team.
Supervise lab equipment maintenance and file documents e.g., calibration reports, data sheets, DO/invoices, service contracts, etc. Support in writing/review procurement/service contract documents (if required).
Maintain inventory and order of lab reagents and supplies, laboratory housekeeping, maintain inventory of preclinical samples and clinical samples using eLABInventory tracking software. Attend IBC safety meeting whenever required on behalf of the team.
Handle clinical packing supplies and shipment coordination. Plan, track, and coordinate biomarker clinical supplies shipment to clinical trial sites (including preparation and provision of the supplies kit).
Provide training (on-site/online) for clinical trial sites in biomarker sample handling. Assist site-lab management activities (resolution of issues), laboratory related protocol deviation review, CAPA (process improvement) and retraining.
Assist in A*STAR IRB document management and application writing. Work closely with clinical operations and HBR officers to ensure proper maintenance of file folders and documentation for audits. Participate in annual HBR audits if required.
Job Requirements
Bachelor of Sciences or Master of Science in Molecular biology or a related discipline. Polytechnic graduates will be considered.
Minimally 2 years of Experience
Good hands-on knowledge of signaling pathways and in-depth knowledge and hands-on experience in of molecular biologic techniques such as RT-qPCR, Western blotting, ELISA, IHC etc.
Attention to details and exact working style to handle clinical samples in GLP-like conditions and GCP compliance
Good spoken and written communication, and computer literacy
Ideally knowledgeable in development and validation for biological assays
Excellent organisational skills and communication skills
Critical thinking, integrity, detailed-oriented, and good teamwork
Knowledge of regulatory requirements e.g., ISO13485 or CLIA/CAP for analytical assay validation is an advantage
Previous industry experience and understanding of drug development is a plus
The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.
Type of Employment : Full-Time
Minimum Experience : 2 Years
Work Location : Immunos
Report job
