Key Responsibilities:
* Provide in-house support to the clinical team according to project requirements, ICH GCP guidelines and local or global regulatory requirements.
* Coordinate 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.
* Support the development, collection and management of essential documents including any translations according to Good Documentation Practice and ICH GCP guidelines.
* Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements.
* Create Investigator Site Files, coordinating the ordering, dispatch and tracking of trial materials.
* Assist CRAs with onsite or remote monitoring visits and follow-up action items from previous monitoring visits.
Minimum Qualifications & Experience:
* Relevant experience in administration in Life Sciences or related field is desirable.
* Ability to work under pressure and to deadlines.
* Comfortable in using IT systems across different platforms.
* Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.
* Degree qualified in Life Science or related field.
We offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
We look for people who are passionate about working in clinical research and biotech, including those who identify as LGBTIQ+, have a disability or have caring responsibilities.