Clinical Trial Solutions Specialist
hace 9 horas
We are united and driven by patients, committed to making a difference in the lives of individuals around the world.
Job SummaryThe Clinical Trial Solutions Specialist will be responsible for delivering high-quality eCOA solutions design consultation to our pharmaceutical/biotechnology industry clients. The successful candidate will align with our project teams and interface with clients and Clario solutions delivery leadership to ensure that clinical protocols are mapped to software solutions efficiently, accurately, and within project scope.
Key Responsibilities:- Coordinating the overall Solutions Design Process for our clients (Trial Sponsors)
- Gathering sponsor requirements and suggesting Clario's best design components to support those requirements
- Creating and maintaining specs for study-specific implementations
- Ensuring consistency between trial data capture, data delivery and database structures to meet client requirements
- Managing the Design Process including communication of design requirements internally and externally with the Customer
- Collaborating with internal teams such as Project Management (to establish and refine scope definitions), Clinical Systems Translation & Licensing (CSTL) (on proper trial questionnaires) and Data Management to ensure the right data is collected to satisfy the sponsor's study needs
- Collaborating with other departments for testing requirements; to support related study issues, and to assist with project scoping and/or change control processes
- Supporting Product Development, Process Development and Study tracking efforts
- BS, BA or equivalent degree in a science/healthcare-related field
- Minimum of 3 years of experience in the execution of clinical trials or equivalent
- Ability to understand and interpret clinical trial documentation such as protocols, questionnaires and other data collection instruments, and clinical data models
- Demonstrated experience in interpretation of client requirements to prepare and document design specifications
- Proven experience in client relations and interactions with clients at all levels
- Familiarity with FDA regulatory processes, clinical research processes
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