Site Management Associate I

Summary

The job is for a Clinical Research Administrator in an international pharmaceutical company. The role involves managing clinical research projects, maintaining systems, and handling documents & information. The ideal candidate should have a college degree in Life Sciences, full proficiency in Czech and English, prior administrative experience in Clinical Research / CRO environment, good organizational skills, detail-orientation, ability to multi-task, team-oriented with excellent customer service skills.

Requirements

• College/University Degree (Life Sciences)
• Full working proficiency in Czech and English
• Prior administrative experience in Clinical Research / CRO environment, preferably in an international setting
• Proficiency in standard MS Office applications
• Good organizational and planning skills, problem-solving abilities, flexibility
• Detail-oriented, able to multi-task and work effectively in a fast-paced environment
• Team-oriented with excellent customer service and interpersonal skills, including a positive attitude to tasks and projects

Responsibilities

• Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team
• Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
• Assists with handling administrative financial tasks
• Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections
• Exchanges data, documents, and other information with the project team and other departments
• Provides assistance with organization of internal team meetings
• Prepares draft minutes of internal team meetings
• Assists with preparation, attendance and follow-up of Investigator’s Meetings, as applicable
• Maintains Trial Master File (TMF)
• Perform TMF review and oversight at country and site level
• Prepares, distributes, and updates Onsite Study Files (OSF) and OSF checklists
• Provides assistance with translations
• Ensures proper safety information flow with investigative sites
• Provides miscellaneous administrative project support (if applicable)