Sma Ii

hace 5 meses


En remoto, España ICON A tiempo completo

As a Clinical Trial Management Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

**What you will be doing**:

- Site level ISF and pharmacy binder creation and availability at site prior to SIV. The cCTA ca be the link between the CRA and the rCTA (regional CTA) in the preparation of the ISF
- Know the requirements for the Site (binders, specific customization of study forms,..) and transmit to the rCTA
- Shipping: follow up and verification of ISF arrival to Sites.
- Create and complete ISF checklist (_Excel CRA tool_)
- Adhoc printing and shipping of document to the Sites
- eTMF filing for Start Up documents from Submission Package and/or IP release Package
- eTMF uploading/maintenance (country level) Amendment Package
- eTMF uploading/maintenance (site level)
- eTMF review: IRB or IEC and other Approvals (country level)
- eTMF review (site level)
- Update Site _Accounts_ with EC (Ethic committee) and HA (Health authority) information
- Update Site _Contacts_ with the data collected during the Start Up Phase
- Set up _Milestones _template at Site level in CTMS and update
- Update _Site Informed Consent_ with the approved documents
- Customization of ICF per site with the date collected in Tracker Site PI information
- Contact sites for collecting Local Lab Ranges

**You are**:

- Bachelor’s degree or above in life sciences, English, and/or management.
- 2 years of clinical trial experience in the pharmaceutical or CRO industry. Exceptions may be considered based on level of training and mentoring available.
- Read, write, and speak fluent English; fluent in host country language may be required.
- Excellent organizational skills and ability to prioritize and multitask.

**Why 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.

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.

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, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.