[Hiring] Licensing and Translation Manager @Cogstate

Role Description

At Cogstate, we’re seeking a Scales Manager, accountable for the procurement, management, and distribution of traditional neuropsychological paper and pencil tests (scales) for use in global clinical trials. The Scales Manager will also coordinate the migration of assessments into electronic format and work alongside the selected eCOA vendor, licensors, and translation vendors to deliver the final product to the Client.

The Scales Manager will serve as the primary point of contact for external vendors including, but not limited to, scales licensors, translation vendors, and other scale-related vendors working on the program. The role requires a strong interest and experience in the pharmaceutical development process, a special aptitude and interest in legal, technical and scientific information, and to be a highly driven individual who demonstrates initiative and delivers against tight timelines.

The role requires extensive written and phone interactions between Cogstate team members in the USA, Australia, and UK, as well as with third-party providers and licensors globally.

Key Responsibilities

• Manage and execute tasks in line with company SOPs and agreed regulatory standards
• Accurate record keeping of all tasks (real-time updates to applicable trackers and maintenance of high-volume emails/site communications)
• Able to follow study changes, re-prioritize assignments based on study needs, and work independently
• 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)
• Periodic travel to attend Investigator Meetings, conferences, partner meetings, and team meetings, based on project and company needs
• Perform research and due diligence, identify scale source documents and supportive materials, and perform preliminary assessments of availability and costs
• Establish and maintain relationships with copyright holders and scales authors
• Procure applicable licenses and permissions and ensure proper written agreements are in place with Cogstate Legal
• Train internal staff regarding permissions and usage of scales, including required copyright notices on materials, limitations of distribution, and other requirements
• Oversee internal compliance to copyright agreements
• Reporting usage to copyright holders as per agreements
• Establish strong working relationships with third party providers
• Review, confirm, and track vendor work and invoices; report to Project Managers or Operational Delivery Leads to ensure alignment with project budgets
• Manage applicable deliverables across a portfolio of projects
• Create/maintain scales databases and libraries as well as proper tracking tools for each project
• 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
• Liaise with Logistics staff to track and report shipping/distribution of materials

Qualifications

• BS/BA degree in psychology or related scientific field
• 3-5 years of clinical trial experience
• Knowledge of intellectual property law
• Experience with copyright law highly preferred
• Understanding of neuropsychological tests and patient or caregiver reported outcomes
• Microsoft Office proficiency and general awareness of information technology concepts and terminology

Skills, Knowledge and Specialist Expertise

• Strong organizational, communication, and interpersonal skills
• Ability to work in a fast-paced environment and manage competing priorities
• Attention to detail with impeccable record keeping and compliance to procedures
• Understanding of clinical trials, regulatory, and legal processes
• Vendor management experience
• Understanding of the clinical development lifecycle and ability to read/review clinical protocols

Benefits

• 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 to 3% 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.

Wage Range

$100,000 — $110,000 USD

Our Culture

We bring our whole selves to work every day. We’re courageous and we deliver together. We’re passionate individuals who enjoy working together. We’re brave enough and care enough to have the right conversations to get the best outcome and are famous for our can-do attitude. We see challenges as opportunities and move with pace to achieve our goals.

If you’re ready to help us in our journey to optimize the measurement of brain health around the world, please apply now!

Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on the company. If you need assistance in applying please email [email protected].

Privacy Notice for Job Applicants: Cogstate is committed to protecting your personal data. We collect and process your information for recruitment purposes in compliance with applicable laws, including the Australian Privacy Principles (APPs), the UK General Data Protection Regulation (UK GDPR), California Consumer Privacy Act (CCPA), Virginia Consumer Data Protection Act (VCDPA), Colorado Privacy Act (CPA), and similar laws in other jurisdictions.

For more information on how we collect, use, and protect your data, and your rights under these laws, you can find Cogstate's privacy policy by clicking here.