Cogstate

Role Description Cogstate Clinicians are clinical psychologists or neuropsychologists responsible for delivering remote clinical interviews and cognitive assessment batteries to subjects with preclinical dementia, enrolled in a pharmaceutical clinical trial. Cogstate provides all consultants with comprehensive, fully compensated training on: - General Cogstate operational policies - Study-specific procedures - Customized clinical interviewing skills - Virtual cognitive assessment prior to performing remote scale administrations Regular supervision and ongoing recalibration of clinical skill set will be provided. - These are contract positions. - They are fully remote. - Hired employees will work on an as-needed basis based on their schedule. - MADRS Administration Experience Required. Key Responsibilities - Remotely administering semi-structured clinical interview assessments and cognitive battery of tests to study subjects and caregivers. - Remotely delivering computerized and traditional cognitive assessments via a tele-health platform. - Scoring completed scale administrations. - Participating in regular clinical skill recalibration activities. - Providing reviews of completed neuropsychological test batteries for central monitoring of data to ensure accuracy in administration and scoring and contribute to the overall success of a clinical trial. - Reviewing response forms and recordings of remote scale administrations and offering feedback to raters via email and telephone communications. Qualifications - Master’s or Doctorate degree in clinical psychology/neuropsychology/behavioral neurology, or related field. - Formal training in clinical interviewing and cognitive assessment. - Minimum of 2 years of relevant experience with direct clinical interviewing and psychological assessment in clinical research industry, academic or clinical settings. - Direct experience with cognitive/behavioral/functional assessment of neurological/psychiatric populations. - Ability to meet deadlines, being highly organized and methodical, with attention to detail to ensure delivery. - Proficiency with MS Office, including Word and Excel, email, teleconference platforms such as Skype, Zoom or other similar applications, and cloud-based storage service. - German Fluency. 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! 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.

• Directing, planning, innovating, and overseeing the development and delivery of products and services related to endpoint management and quality assurance in global clinical trials of AD and other related neurodegenerative disease therapeutic areas. • Support delivery of endpoint data quality monitoring plans for AD trial related services. • Drive the definition and scope of study services. • Supports driving the scientific decisions around neurodegenerative indication services/supports. • Support the publication/presentations strategy for AD. • Contribute to publications and conference presentations in AD. • Support delivery of scientific services in awarded studies.

Role Description At Cogstate, we’re seeking an Associate, Learning Services responsible for serving as an individual contributor within the Learning Services function, owning moderately to highly complex LMS workstreams and supporting the delivery of scalable learning solutions. This role operates between execution and advanced system leadership, translating learning requirements into effective LMS configurations while maintaining quality, reliability, and timeliness. The Associate applies strong LMS expertise and sound judgment to independently manage complex configurations, advanced troubleshooting, and stakeholder delivery. This role supports system optimization efforts and integrations as needed, while partnering closely with the Senior Manager and providing functional support to other team members to ensure consistent execution. Key Responsibilities - Design, build, and maintain moderately complex LMS configurations aligned to learning requirements - Manage curricula, assignments, rules, and course structures within defined standards - Independently troubleshoot and resolve LMS issues and escalations - Ensure LMS builds are accurate, scalable, and delivered on time - Support LMS-related integrations, data workflows, and enhancements as assigned - Validate LMS data accuracy and reporting outputs - Generate and interpret reports to support learning delivery and stakeholder needs - Identify and raise opportunities for system or process improvements - Act as a functional partner to Learning, Operations, P&C, and other stakeholders - Translate learning and business requirements into viable LMS solutions - Communicate timelines, risks, and delivery status clearly and proactively - Balance multiple concurrent LMS workstreams effectively - Uphold LMS standards, quality controls, and governance practices - Support testing and rollout of LMS enhancements or updates - Reinforce execution standards and escalation protocols Qualifications - Bachelor’s degree or equivalent practical experience in learning technology, systems administration, or a related field - 3-5+ years of experience administering or supporting a Learning Management System - Experience managing complex LMS configurations and learning builds - Experience supporting multiple concurrent learning initiatives - Experience with Absorb LMS or similar enterprise LMS platforms - Experience supporting LMS integrations or data workflows - Experience in regulated or SOP-driven environments - Advanced LMS administration and troubleshooting skills - Ability to work with LMS data for reporting and validation - Advanced proficiency in Microsoft 365 - Ability to interpret requirements and translate them into LMS solutions - Exposure to eLearning content tools or standards (e.g., SCORM, Articulate) - Familiarity with automation, integrations, or learning analytics concepts Skills, Knowledge and Specialist Expertise - Ability to work independently and own LMS workstreams end-to-end - Strong analytical and problem-solving skills - Clear communication with technical and non-technical stakeholders - Ability to manage competing priorities and escalate appropriately - Experience contributing to system or process optimization efforts - Experience working independently in a fast-paced, cross-functional environment Benefits - Remote Work Practices: Cogstate is a virtual first company. Employees can work from anywhere where Cogstate is registered to business within the United States, Australia, or the United Kingdom! - Generous Paid Time-off: 20 days of vacation leave, 10 days of personal leave, and 10 paid public holidays. - 401(k) Matching: We match up to 3% of your yearly salary in Cogstate’s 401k program. - Competitive Salary: Competitive base salaries plus additional earning opportunities based on the position. - Health, Dental & Vision Coverage: Comprehensive health & dental insurance options with competitive company contributions, plus 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: Robust learning program from mentorships to assistance with programs to improve knowledge or obtain certifications in applicable areas of interest. Wage Range $60,000 — $75,000 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!

Role Description At Cogstate, we’re seeking a Senior Project Manager accountable for managing multiple Cogstate projects overseeing the delivery of Cogstate Services. The Senior Project Manager will: - Have experience with the pharmaceutical development process. - Possess a special aptitude and interest in scientific and technical information. - Motivate and mentor project and portfolio teams. - Demonstrate initiative and deliver against tight timelines in an agile environment. - Have demonstrated experience managing a full workload of clinical projects and/or internal development projects. - Have a growing awareness of information technology concepts and terminology. - Experience with direct and indirect people management. - Handle stressful situations with confidence and composure. - Communicate calmly and effectively with internal and external stakeholders, particularly in areas of disagreement. This role will require extensive communication and interactions across multiple time zones with staff, Sponsors, and clinical sites in countries all over the world. Key Responsibilities - Manage projects and execute tasks in line with company SOPs and agreed regulatory standards. - Manage client relationships as main POC for individual studies and some sponsor portfolios. - Independently lead Cogstate’s complex global clinical trials projects. - Manage Clinical Trials projects in Start-Up, Conduct, or Close-Out phases (multiple projects at one time). - Proactively manage risks with confidence. - Attend Investigator Meetings (as needed) and ensure Cogstate is well represented. - Work in an Agile environment with a given Portfolio Team. - Oversight of resourcing and financials across a Portfolio of Projects. - Generate invoices for assigned projects in alignment with expected timelines and project progress. - Actively maintain the change order process. - Oversee internal projects focused on developing processes for implementing new technologies. - Develop operational deployment plans for new systems, including training. - Work closely with Business Development and project team managing relationships and supporting proposals for key accounts. - Potential to line manage or indirectly manage and mentor other project management team members and clinical operations staff in the future. - Analyze reports for project hours and budget utilization. - Forecast invoicing based on expected timeline and progress of the study. - Review Work Orders and determine deliverables and timelines for projects. - Ensure accurate reporting to internal and external stakeholders on service delivery and progress. People/Staff Management - Demonstrate high performance in mentoring other project management team members and clinical staff. - Develop/contribute to playbooks for new Sponsors/Partners/systems. - Participate in internal and external audits and inspections. - Support metrics reporting to sponsors. Qualifications - Bachelor's degree in a scientific, business, or technical discipline (psychology, nursing, biology, sociology, computer science, or engineering). - Master’s preferred (science or business) but not mandatory. - PMP Certification (preferred but not mandatory). - Previous CRO experience preferable. - Previous CNS experience. - 7+ Years Project Management experience in Pharmaceutical, Biotech, or CRO environment. - Supervisory/mentoring experience (preferred but not mandatory). - Relationship Management Experience. - Microsoft Office proficiency. - Budget management experience. Benefits - Remote Work Practices: Cogstate is a virtual first company. - Generous Paid Time-off: 20 days of vacation leave, 10 days of personal leave, and 10 paid public holidays. - 401(k) Matching: We match up to 3% of your yearly salary in Cogstate’s 401k program. - Competitive Salary: Competitive base salaries plus additional earning opportunities. - Health, Dental & Vision Coverage: Comprehensive health & dental insurance options. - Short-Term & Long Term Disability Life Insurance: 100% employer sponsored. - Pre-Tax Benefits: Healthcare and Dependent Care Flexible Spending Accounts. - Learning & Development Opportunities: Robust learning program from mentorships to assistance with programs to improve knowledge or obtain certifications. Wage Range $125,000 — $135,000 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. 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.

• Work with study teams across a variety of functional areas to ease bandwidth strain on Coordinator responsibilities detailed below. • Processing clinician/rater forms and documenting data via status trackers and ePortal/LMS training systems. • Review and process submitted clinician/rater surveys and deploy applicable LMS training modules. • Schedule 1:1 training video conferences between site raters and Cogstate Rater Services staff. • Hardware shipment scheduling and documentation management. • Documenting real time updates to applicable status trackers, coordinating high volume email correspondence, communicating status updates to clinicians/raters, electronic records filing. • Point of contact for clinician/rater support questions. • Direct communication with site coordinators at clinical settings, activity and communication tracking and general support throughout study. • Interact with CRAs for site monitoring activities.

• Assist Senior Project Managers and Project Managers with larger Global clinical trials across all phases; lead own projects with limited support from Project Manager supervisor. • Fully support day-to-day Client Solutions activities with minimal oversight (preparing meeting agendas and minutes, following up with team members on action items, reviewing third party invoicing, raising invoices). • Plan and track project specific tasks (maintaining Cogstate systems, maintaining study timelines, maintaining action, decision and risk logs). • Manage client relationships as a study POC; manage risks in a proactive fashion. • Develop understanding of Cogstate service delivery within operational, financial and regulatory constraints. • Interact with statistical, science and data management teams internally to identify data quality related issues and risks to clinical activities, develop contingency and mitigation plans to minimize risks, and provide updates and metrics to Sponsor. • Contribute to internal project team leadership utilizing Agile methodologies. • Attending Investigator Meetings and ensure Cogstate is well represented. • With support from supervisor, request resources across platform lines and ensure team member follow pre-determined hours allocated in budget. • With Supervision, work with Leadership to determine capacity within Portfolio Team to take on additional work. • Interact with site services, science and data management teams internally to identify rater training and data quality related issues and risks to clinical activities, develop contingency and mitigation plans to minimize risks, and provide updates and metrics to Sponsor. • Manage project to target gross profit consistently. • Accurate and timely financial forecasting and invoicing. • Assess need for change in scope and lead Change Order Process. • Maintain a strong understanding of the broader impact of invoicing on company financials. • With supervision, analyze reports for project hours and budget utilization and making course corrections in conjunction with Operations Line Managers. • With support from supervisor, ability to review Work Orders and determine deliverables and timelines for project. • Maintain project narrative for external and internal stakeholders. Ensure accurate reporting on service delivery and progress.

• Assist Senior Project Managers and Project Managers with larger Global clinical trials across all phases; lead own projects with limited support from Project Manager supervisor. • Fully support day-to-day Client Solutions activities with minimal oversight (preparing meeting agendas and minutes, following up with team members on action items, reviewing third party invoicing, raising invoices). • Plan and track project specific tasks. • Manage client relationships as a study POC; manage risks in a proactive fashion. • Develop understanding of Cogstate service delivery within operational, financial and regulatory constraints. • Interact with statistical, science and data management teams internally to identify data quality related issues and risks to clinical activities. • Contribute to internal project team leadership utilizing Agile methodologies. • Attend Investigator Meetings and ensure Cogstate is well represented. • Request resources across platform lines and ensure team member follow pre-determined hours allocated in budget. • Analyze reports for project hours and budget utilization and make course corrections in conjunction with Operations Line Managers. • Maintain project narrative for external and internal stakeholders.

• 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 ensures 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) • This role requires 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 • Project Management • Manage applicable deliverables across a portfolio of projects • Create/maintain scales databases and libraries as well as proper tracking tools for each project • Direct work of support staff, including delegating tasks and ensuring quality and timely delivery • 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

• Oversee the scientific delivery of psychiatry clinical trial services across a portfolio of studies, including rater training and central monitoring. • Contribute to definition and implementation of study-specific delivery plans for endpoint quality, including integration of central monitoring and review workflows. • Provide direction to internal study teams on feasibility, scale selection, administration standards, and timing of deliverables. • Serve as the primary scientific point of contact for assigned studies, ensuring clarity and consistency in internal and sponsor communications. • Contribute to design and implementation of rater training programs (e.g., MADRS, HAM-D, HAM-A, YMRS), including certification, calibration, and remediation pathways. • Monitor central monitoring outputs, including identification of data quality signals, rater drift, and protocol deviations, and guide appropriate follow-up actions. • Support the resolution of scientific and data quality escalations arising from central monitoring and study review activities. • Develop central monitoring resources to systematize feedback. • Collaborate with Project Management to ensure efficient and profitable delivery of services, including resource allocation and workflow optimization. • Contribute to the development and standardization of SOPs, training materials, and operational guidelines for psychiatry trials. • Support staff development within scientific and rater training teams, including mentoring and performance feedback. • Contribute to the development and refinement of psychiatry-focused products and services, including rater training programs, central monitoring methodologies, and scale-specific guidance. • Support innovation in endpoint quality assurance and approaches for detecting data quality issues. • Contribute to the design and interpretation of metrics related to rater performance, endpoint reliability, and data quality. • Analyze patterns in clinical trial data to identify risks such as placebo response inflation, rater drift, and scoring inconsistencies. • Provide scientific consultation on study design, scale selection, administration strategy, and risk mitigation. • Support business development through scientific input in proposals • Drive scientific dissemination through publications, conference presentations, and internal knowledge-sharing initiatives. • Contribute to advancing best practices in psychiatric endpoint assessment and central monitoring.

• Partner closely with the Business Development Director, Strategic Accounts to secure and expand profitable New Business Awards (NBAs). • Identify, qualify, and advance new business opportunities. • Support the development and execution of strategic account plans. • Lead end-to-end development of strategic proposals and RFIs. • Manage high-value complex B2B deals requiring strong commercial judgement. • Conduct ongoing research into named strategic accounts to identify new opportunities. • Build and maintain strong, senior-level customer relationships. • Maintain accurate records of strategic account activity within SalesForce.com database.