Specialist Study Management

Study Start Up Clinical Study Administrator (SSU CSA)

Strong verbal & written communication skills

Strong organizational skills

Previous administrative experience

Computer proficiency

Key Responsibilities:

• SSU CSA is responsible for ensuring vendor spreadsheets are completed correctly and processed according to study team guidelines.
• SSU CSA is responsible for reviewing and processing all sub Investigator documents. SSU CSA will attend weekly Study Team meetings to report on vendor spreadsheets, sub I document progression, etc. All responsibilities are performed according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations.
• A SSU CSA with longer tenure and experience may take on additional responsibilities from the SSU Manager.

Typical Accountabilities:

• Assist SSU Manager with obtaining and maintaining essential documents in compliance with ICH-GCP, AZ Procedural Documents.
• Review and process start up documents, including Sub Investigator's documents in compliance with ICH-GCP, AZ Procedural Documents.
• Drive delivery of regulatory documents at the sites. Proactively identify delays in start-up activities and the risks to the activation plan.
• Attend study team meetings and be prepared to provide a report on vendor spreadsheet status and sub I document status.
• Set-up, populate and accurately maintain information in tracking and communication tools (e.g. Veeva Clinical, Box, etc.) and support others in the usage of these systems.

Education, Qualifications,

Skills and Experience:

• Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers, completed high school and further studies in administration.
• Experience with vendor management, strong verbal & written communication skills, and strong organizational skills.
• Previous administrative experience.
• Proven organizational and administrative skills.
• Computer proficiency.
• Very good knowledge of spoken and written English.
• Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

Desirable Qualifications,

Skills and Experience:

• Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to study Start-up, together with an understanding of the ICH/GCP guidelines.
• Ability to develop advanced computer skills to increase efficiency in day-to-day tasks.
• Good interpersonal skills and ability to work in an international team environment.
• Willingness and ability to train others on study administration procedures.
• Integrity and high ethical standards.