Ref #: 27539

Employment type: Permanent - Full-Time

Location: Italy

Posted: 17-Mar-2021

Description

Key responsibilities:

* Oversight of all trial documentation for assigned clinical trial:
* CTA documentation to support affiliates in HA and EC submissions
* Ensure overview of local requirements
* eTMF handling and archiving
* Timely uploading of trial documentation in electronic filing system
* Compliance check of electronic filing system
* Ensure timely and adequate archiving at closeout
* Providing Investigator Trial Master Files (ITMFs) set-up and core input
* Supporting and tracking trial related payments (e.g. Investigator fees),
including invoice processing
* Support in the organization of local meetings
* Supporting local distribution of materials to sites
* Supporting clinical supplies management and tracking all relevant processes
* Super User as relevant (e.g. electronic filing system)
* Other administrative tasks as relevant
* Collaboration with CDC, local clinical and CMR and other cross-functional
roles to ensure successful planning and conduct of clinical trial within the
countries involved.
* Ensure and drive consistency in eTMF handling process across CDC adjacent
affiliate countries.
* Additional tasks as agreed with functional management and seniority in role
progresses


Required experience and qualifications:

* Bachelor’s degree or RN
* Associate’s degree & proven directly related experience
* Work experience in life sciences or medically related field,
* Clinical trial process experience
* Work involving data entry into systems/databases
* 1/2 years of previous experience in the role



Why join the DOCS team at ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

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