Operations Associate, Clinical Assessment Training & Surveillance - Europe

• Track the collection, entry, and distribution of rater experience qualification data

• Review and may develop study specific rater training web portal specifications for portal readiness

• Assist in coordinating logistical matters and prepare materials for Investigators’ Meetings, which Associate may attend

• Edit / format materials such as for rater training, including Excel spreadsheets, PowerPoint training slides, and Microsoft Word

• Conduct scale management activities, such as obtaining scale licenses, translations, regulatory authorizations, and Sponsor approvals

• Track incoming source documentation to ensure timeliness of source reviews and provide data to the Sponsor and study team

• Communicate with research sites to ensure rater training and data surveillance plan guidelines are followed

• Provide CAT data for the CAT Final Study Report completion and ensure proper formatting of document

• Highly organized, detail- and service-oriented

• Meets timelines consistently and be able to effectively work under pressure

• Continuously open to constructive, developmental feedback

• Skilled in written and verbal communication in order to clearly and concisely present information

• High level of interpersonal skills in a fast-paced, deadline oriented, and changing environment

• Able to manage multiple tasks and many administrative details in a fast-paced and constantly changing environment

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• Excellent proficiency in all MS-Office applications, including Microsoft Word, Adobe, Excel, and PowerPoint

• At least 1+ years clinical trial experience

• Demonstrable knowledge of operational aspects Phase I-IV clinical

• Ample knowledge of SOPs and ICH/GCP/regulatory guidelines

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• Fluency in English (will be required to write, speak and understand English to conduct day-to-day business)

• The role requires travel domestically and internationally in order to attend key meetings. The global nature of the position may also require the incumbent to occasionally manage their time flexibly in order to be responsive to stakeholders in different time zones.

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