Associate, Scale Management

That’s why we’re seeking a Associate, Scale Management accountable for the production, quality control, and distribution of traditional neuropsychological tests (scales) for use in global clinical trials.  The Associate serves as the primary point of contact for document design, production, and shipping requests involving scale materials. The Associate may also be in contact with Cogstate Legal and external vendors including, but not limited to, scales licensors, translation vendors, eCOA vendors and other scale-related vendors working on the program.  

The role requires an aptitude and interest in design, technical and scientific information, and to be a highly driven individual who demonstrates initiative and delivers against tight timelines.  

The role requires written and phone interactions between sponsors, Cogstate offices, as well as with third-party providers and licensors globally.

Key Responsibilities

• Accurate record keeping of all tasks (real-time updates to applicable trackers and maintenance of high-volume emails/site communications).   
• Direct work of support staff, including delegating tasks and ensuring quality and timely delivery.  
• Support activities of Scale Managers with minimal oversight on assigned tasks. 
• Drive activities and ensure timely delivery of project tasks leading to the completion of client deliverables.
• Management and delivery of phase I-III clinical trials (understanding and tracking against the project SOW).
• Assumes a SM Lead role for small to medium size studies. 
• Crosstrain on Rater Servies tasks to provide additional support if needed.  
• Oversee production of study-specific source documents and scale modifications while documenting and reporting scales modifications as required to copyright holders.
• Liaise with Clinical Science Leads, project team members, and sponsor teams to ensure efficient source document creation in adherence to study timelines and study protocol requirements.
• Oversee production and quality control of scales materials such as study binders.
• Performing QC or coordinating QC of all materials including Source Documents; Translations; Printed Component and eCOA forms.
• Resolving any quality issues that arise during a study (i.e., sending updated forms, creating memos to sites, documentation of the error, etc.).
• Liaise with Logistics staff to track and report shipping/distribution of materials.
• Filling orders of scale shipments.
• Maintaining the trackers / OMS.
• Assisting with hardware shipments and returns.
• Perform research and due diligence, identify scale source documents and supportive materials, and perform preliminary assessments of availability and costs.
• Procure applicable licenses and permissions and ensure proper written agreements are in place with Cogstate Legal.
• Oversee internal compliance to copyright agreements.
• Reporting usage to copyright holders as per agreements. 
• Review, confirm, and track vendor work and invoices; report to Project Managers or Operational Delivery Leads to ensure alignment with project budgets.
• Maintain scales databases and libraries as well as proper tracking tools for each project.

Requirements

• Bachelor's degree and/or 3+ years of relevant experience
• 2+ years’ work experience in clinical trials or related fields
• Project coordination or management experience is a plus 
• Experience in editorial or quality assurance (QA) processes is a plus
• Excellent communication skills (written and oral) in English 
• Ability to multi-task, being highly organized and methodical, with attention to detail 
• Strong people skills within the team and with customers and third-party providers 
• Demonstrated ability to learn quickly, work independently, plan and be proactive 
• Strong level of computer literacy (experience working with clinical software preferable) 
• Ability to thrive in a fast-paced, growing environment

What’s In It For You

• Remote Work Practices: Cogstate is a virtual first company. Cogstate employees can work from anywhere where Cogstate is registered to business within the United States, Australia, or the United Kingdom!
• Generous Paid Time-off: Cogstate employees receive 20 days of vacation leave, 10 days of personal leave and 10 paid public holidays.
• 401(k) Matching: As you invest in yourself and your future, Cogstate invests in you too: we match up to3% of your yearly salary in Cogstate’s 401k program.
• Competitive Salary: We offer competitive base salaries plus additional earning opportunities based on the position.
• Health, Dental & Vision Coverage: We've invested in comprehensive health & dental insurance options with competitive company contributions to help when you need it most. We also offer free vision insurance for all full-time employees.
• Short-Term & Long Term Disability Life Insurance: 100% employer sponsored
• Pre-Tax Benefits: Healthcare and Dependent Care Flexible Spending Accounts
• Learning & Development Opportunities: Cogstate offers a robust learning program from mentorships to assistance with programs to improve knowledge or obtain certifications in applicable areas of interest.