Clinical Trial Associate

For our pharmaceutical client in Rotkreuz we are looking for an experience ADMINISTRATIVE EXPERT.

Some of your tasks will be:

* Liaises with clinical team to help compile initial and amended regulatory document package for the central and local IRB/IECs and sites.
* Collaborates with teams to ensure parallel HA and IRB/IECs submissions.
* Tracks the status of regulatory readiness and alert the Clinical Study Manager and MA appropriately to any issues/challenges in getting sites ready.
* Work with translating agencies to ensure translation of relevant clinical study documents.
* Ensures appropriate versions of legal documents (CTA and other agreements) are used and ensure database is kept current. In collaboration with local clinical team responsible for contract management with investigators, vendors. Liaise with legal to track and process agreements.
* Responsible for scanning essential trial related documents/communications in relevant systems.
* In collaboration with CSMs and CRAs, responsible for the set-up and maintenance of country and site specific TMFs continuously up to date in accordance with regulatory and Novartis requirements.
Clinical Trial Supplies.
* Assists local trial team with the creation, ordering, and mailing of any study tools including recruitment materials as well as newsletters, blast email communications, blast faxes etc.
* Supports local trial team with ordering/tracking/coordinating shipment of any necessary trials supplies
Finance.
* Provides support to CSM for trial budget planning, forecast and accounting.
* Tracks, processes and releases milestone payments to study sites in collaboration with local study team and finance.
* Tracks, processes and releases payments to vendors in collaboration with local study team and finance.
* In collaboration with local finance supports the refund process.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.