Ref #: 25004

Employment type: Permanent - Full-Time

Location: Hungary

Posted: 05-Nov-2020

Description

Description:
•* Partners with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.
•* Supports the local study team in performing site feasibility and/or country feasibility.
•* Maintains site level protocol information in Trial Management Systems (e.g. CTMS).
•* In liaison with the LTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.
•* Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval
* Supports the LTM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA.
* Supports the SM/LTM in collecting and maintaining all documents throughout the trial and posttrial in both eTMF(i.e., IF/LAF sections) and paper files.
•* Distributes, collect, review, and track regulatory documents, agreements and training documentation.
•* Collects and tracks Financial Disclosure information at appropriate time points.

Profile:

* Skills set corresponding with preferentially 0-2 years relevant clinical trial experience or equivalent.
* Proficient in English language.
* Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
* Strong interpersonal and negotiating skills.
* Excellent organizational skills and the ability to collaborate and handle multiple priorities within a
matrix environment. Perform activities in a timely and accurate manner.