Specialist Study Management

***Please use the attached/revised ERMO Resume Template for resume submissions*** RECOMMENDED BILL RATE MAX: ***/HR. *You may determine the appropriate pay rate for your candidate; keeping in mind the resulting bill rate should be considered financially responsible according to your existing MSA. If you feel the recommended bill rate is not in line with market demands, please contact me to discuss prior to submitting the candidate. For this open recruitment, please direct communications to main point of contact ***. Thank you!


Note: Candidates should be available to start as soon as possible. Start date could change, to an earlier date, depending on when the right candidate has been identified.


Location- Remote (Must be able to work EST time/hours)
Internal AZ Title: Study Start Up Clinical Study Administrator (SSU CSA)


Candidate:


REQUIRED:
1. Strong verbal & written communication skills
2. Strong organizational skills
3. Previous administrative experience
4. Computer proficiency


Key Responsibilities:
• SSU CSA is responsible for ensuring vendor spreadsheets are completed correctly
and processed (submitted to vendor or global team) 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