Senior Rater Training Manager
New Haven , CT 06501
Posted 1 week ago
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The Senior Rater Training Manager (Sr. RTM) is responsible for managing a portfolio of Cogstate clinical trial projects which may include the delivery of computerized cognitive tests, rater training services and central data monitoring activities (paper or eCOA). The Sr. RTM will have a strong, vested interest in the pharmaceutical development process, technical and scientific information, and be a highly driven individual who demonstrates initiative and delivers against tight timelines. In addition, the Sr. RTM will have confidence and composure in handling stressful situations communicating calmly and effectively with internal and external stakeholders, particularly in areas of disagreement. The Sr. RTM will have demonstrated experience managing a full workload of clinical projects and a growing awareness of technology concepts and terminology as it pertains to their functional areas. These functional areas include Study Start-Up Activities, Site Training/Monitoring, In-Study Conduct Management, CRO partnership activities as well as third-party vendor management. Given this experience, the Sr. RTM may act as the subject matter expert and be accountable for conducting successful complex scales/rater training studies from study award through close-out.
- Working collaboratively with internal stakeholders in the management and delivery of complex Rater Training and Central Monitoring services for phase I-IV clinical trials - especially around implementation for projects with new service offerings in scope
- Proactively providing Rater Training and Central Monitoring project plan updates to relevant internal and external stakeholders
- Assessing the inherent risks of various situations and making timely decisions with limited support
- Collaborating with various internal and external stakeholders in the development of rater training curriculums and central monitoring materials for a portfolio of clinical trials
- Supporting departmental leadership in commercialization efforts and standardization of new procedures and affiliated documentation
- Serving as a Subject Matter Expert for Rater Training and Central Monitoring services and applications
- Working with third-party vendors, that support Rater Training and Site Support services (with a focus on EDC platforms and eCOA technologies), to ensure high performance and quality on their deliverables
- Understanding and tracking against the project SOW including budgetary oversight and contributing to scope change orders relevant to service delivery.
- Tracking and escalating out of scope activities
- Directing work of Rater Training Managers, Associates and/or Coordinators and ensuring compliance to Cogstates project delivery standards and SOP guidelines.
- Supervision for 3-4 direct reports and mentoring of junior team members on their projects in matrix environment
- Bachelor's degree (business or scientific discipline preferred). Masters Degree preferred.
- 7+ Years Clinical Trial Management experience in Pharmaceutical, Biotech, or CRO environment
- Understanding of the clinical development lifecycle and ability to read/review clinical protocols
- At least 4 years of direct supervisory experience
- Budget management experience
- Vendor or Third-Party management experience
- Understanding of neuropsychological tests and patient or caregiver reported outcomes (preferred but not mandatory)
- PMP Certification is a plusBachelor's degree (business or scientific discipline preferred).
Cogstate is a leading cognitive science company focused on optimizing the measurement of cognition (brain function) to guide decision-making in clinical trials, academic research and healthcare. Cogstate commercializes rapid, reliable and highly sensitive computerised cognitive tests and provides expert support for traditional neurological assessments. Science, innovation and excellence in delivery are at the core of everything we do. Cogstate offers health, dental, and vision benefits as well as 401K plan matching. Cogstate, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or genetics.
Cogstate Competencies, essential to achieving and executing our goals at every level
Do the Right thing
- We are honest and dependable. We keep our promises, act with integrity and foster trust through fairness, transparency, and open communication
Think like a customer
- We see our customers challenges as our own and strive to help them succeed. We listen, learn what makes them tick and adapt to creatively meet their needs.
Take care of each other
- We work together to tackle big challenges that can only be achieved through the collective and caring efforts of diverse individuals. We show appreciation, value differences, and celebrate wins.
Lead with science
- We are determined, curious thinkers who use knowledge and data to challenge the status quo and redefine what is possible. We are experts in our fields who are trusted by our customers.
- We are accountable to excellence and hold ourselves to high standards. We are problem solvers at heart and quick to both identify obstacles and bring solutions
- We show resilience in the face of hardship to do the messy work of innovating. We stick to difficult tasks with grit and determination. We iterate, experiment, and embrace failing forward.
See the big picture
- We are driven by an understanding that the work we do matters. Our personal connections to the mission may be different, but we know our why and it motivates us to do our best work.