Ref #: 30427

Employment type: Fixed term - Full-Time

Location: Rome

Posted: 06-Jul-2021


The role:

* 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

To be successful in the role, you will have:

* 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 and/or business support role

The role is located in Rome

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.