Job Description

Site Management

• Under supervision, exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team
• Under supervision, may assist with clinical supplies (including medication) order, receipt, inventory storage, distribution, return/recall and reconciliation
• Under supervision, supports CA submissions and notifications
• Under supervision, assists with handling administrative financial tasks
• Under supervision, may assist with preparation and follow-up of site, TMF and systems´ audits and inspections

Other Communication

• Under supervision, exchanges data, documents, and other information with the project team and other departments
• Under supervision, provides assistance with organization of internal team meetings
• Under supervision, prepares draft minutes of internal team meetings
• Under supervision, assists with preparation, attendance and follow-up of Investigator’s Meetings, as applicable
• Under supervision, maintains study-specific and corporate tracking systems

Document Management

• Under supervision, maintains Trial Master File (TMF)
• Under supervision, may perform TMF review and oversight at country and site level
• Under supervision, prepares, distributes, and updates Onsite Study Files (OSF) and OSF checklists
• Under supervision, provides assistance with translations

Safety Management

• Under supervision, may assist with safety information flow between investigative sites and the project team
• Corporate/Departmental Assignments
• Under supervision, may provide administrative assistance with feasibility research

Other Assistance

• Provides miscellaneous administrative project support (if applicable)

Qualifications

College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.

• Basic proficiency in MS Word
• Basic proficiency in MS Excel
• Basic proficiency in MS Outlook
• Basic proficiency in MS Power Point
• Basic proficiency in Skype for Business
• Knowledge (following proper training) of applicable software and project specific systems
• Basic typing skills in English (min. 40 words per minute)

Additional Information

All your information will be kept confidential according to EEO guidelines.