Internal Job Description
Perform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and / or international regulations, standard operating procedures (SOPs), project requirements and contractual / budgetary guidelines.
Provide support to the team in the preparation, handling, distribution, filing and archiving of documentation according to the scope of work and standard operating procedures.
Review documents for completeness, consistency and accuracy, under guidance of senior staff
Prepare client deliverable documents using appropriate tools and draft text for straightforward documents, under guidance of senior staff
Completion of relevant Clinical Trial Management System (CTMS) fields, databases, tracking tools, timelines and project plan with project specific information
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Exposure to MS Applications including but not limited to Microsoft Word, Excel and PowerPoint
Effective written and verbal communication skills including good command of English / Spanish language
Effective time management skills
Results and detail-oriented approach to work delivery and output
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Strong listening and phone skills
Good data entry skills