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Clinical Operations Assistant
7 giorni fa
When our values align, there's no limit to what we can achieve.
Due to promotion, we are now looking for a Clinical Operations Assistant for the team in Milan, Italy.
Key Accountabilities:
Track, scan, code, and apply naming convention and send documents to the relevant study Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan.
Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP)
Photocopy, print distribute and retrieval of documents, as needed
Maintain basic quality check procedures to ensure accurate maintenance of documents
Tracking/maintenance of the Clinical Trial Management System (CTMS) and study specific site trackers (Client additional request only)
Monitoring of the status of systems and processes (e.g. annual reporting obligations, Site Compliance regarding Safety Information System (SIS) etc.) to ensure compliance
Organization of translations of study document (e.g. contacting translation members (CMS) company, requesting approval via Oracle, following up with translation company to ensure timely delivery)
Payment/invoice processing including internal follow up with payment specialists in Finance
Courier shipment of study document to the sites, vender and clients
Collection of internal signatures for site documents (e.g. confidentiality agreement or clinical site agreements) within Parexel
Qualifications
On your first day we’ll expect you to have:
Previous relevant work experience (preferred).
Ability to perform clinical monitoring activities under supervision from the COL/LM.
Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline.
Strong interpersonal, written, and verbal communication skills within a matrixed team.
Experience working in a self-driven capacity, with a sense of urgency and limited oversight.
A client-focused approach to work and flexible attitude with respect to assignments/new learning.
The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).
An honest and ethical work approach to promote the development of life changing treatments for patients.
Strong computer skills, including but not limited to the knowledge of MS-Office products such as Excel and Word.
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