Support the clinical team's inhouse activities on assigned projects.
Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs.
Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs.
Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements. Follow up with relevant team to update and maintain site milestones, subject tracking and PISCF's, ensuring accuracy and completeness of the data.
Create the Investigator Site Files, co-ordinating the ordering, dispatch and tracking of trial materials (e.g., patient cards and diaries, lab supplies, drug supplies, etc.) according to the logistical requirements of the study. Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA.
May assist the CRAs with the preparation of onsite or remote monitoring visits and follow-up action items from previous monitoring visits.
May assist IRB submission (safety reporting: other site SUSAR, Line listing, DSUR, including site communication, CSR submission etc.) including tracker management during project maintenance and close out phase.
Qualifications
Relevant experience in administration in Life Sciences or related field or similar would be preferable.
Ability to work under pressure and to deadlines.
Comfortable in using inhouse IT systems across different platforms.
Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.
Degree qualified in Life Science or related field.
