Clinical Operations Assistant

· 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 translationcompany, 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

· Assumes the ability to meet the requirements of a COA with a high degree of proficiency

· Effective time management in order to meet daily metrics or team objectives

· Able to work independently but seek guidance when necessary, escalating issues as required

Qualifications· Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.

· Maintain a basic knowledge and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations and applicable PAREXEL procedures

· Good oral and written communication skills to internal and external customer

· Ability to prioritize multiple tasks and achieve project timeline

· High commitment to and performs consistently high quality work

· Good written English skills

· Experience in office management in an international environment would be advisable· Relevant qualification or equivalent experience required

· High school diploma – ideally degree in life science or other related background - preferred