锦鲤求职岗位描述
YOUR TASKS AND RESPONSIBILITIES
Plans, organizes, monitors and enforces the collection, processing, storage and logistics of biosamples within a study.
Accountable for preparation of study related documents (biosample management plan and report, sample handling sheets, etc.) as well as development of shipment schedules, sampling and storage requirements in close collaboration with central and analytical laboratories.
Support the content of PK, IM, PGt and BM sections of the clinical study protocol, Informed Consent form and review of biosampling pages in EDC.
Accountable for the biosample-related set-up of the central laboratory (kit provisioning, lab manual, logistics etc.)
Responsible for providing critical support for CHGRAO activities, such as CHGRAO application, import and export license, CIQ application, as well as supporting China clinical sites with all related activities.
Responsible for handling of samples according to protocol, SOPs, GCP and ICH-guidelines.
Training of monitors, study nurses and investigators.
Supports the study team with the submission to IRBs and ECs and responds to IRB/EC requests.
Responsible for the tracking, monitoring and documentation of biosampling activities (in the Biosample Management System).
WHO YOU ARE
Degree in Life Sciences (MSc, PhD).
A minimum of 2 years’ experience in clinical research, with good understanding of clinical development processes (e.g. study management or CRA).
Detailed knowledge of the ethical, legal and logistic requirements of obtaining and processing human biological samples.
Proven clinical development experience of working in teams running clinical studies, monitoring clinical studies or experience of working in clinical studies at an investigator site.
Knowledge of BM and PK analytical processes.
Proven ability to plan, organize and manage multiple projects under pressure.
Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams).
Effective communication and negotiation skills in English.
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