Senior Clinical Trial Manager
Abata TherapeuticsFull Time
Senior (5 to 8 years)
The Project Design Manager must be able to independently review clinical trial protocols and interpret Central Lab responsibilities based on protocol definitions and budgeted services. The ability to work on a team, as well as independently, while maintaining clear communication and attention to detail is key to this role. The candidate must also be able to work under general supervision and guidance from project design leads and managers.
The Project Design Manager will advise Project Managers on procedural and budgetary items and the necessity for change due to database configuration requirements. This role supports the Project Manager in the review of draft laboratory specifications document for consistency with protocol and budgeted requirements, providing feedback regarding budget and/or protocol discrepancies, system design requirements, and/or concerns. Responsibilities include ensuring consistency of database design across sponsors and/or programs, configuring Collection Flow Chart (CFC) based on protocol testing requirements, assay volumes, testing location, sample stability, and frequency of testing. The role also involves determining appropriate testing to sample allocation based on testing schedule, processing instructions, sample disposition, and third-party lab requirements, as well as configuring Kit Specifications and sample labels based on client needs and collection requirements. The Project Design Manager will attend meetings, provide Project Manager support during laboratory specifications development discussions with clients, and work cross-departmentally to ensure study database design meets client and internal requirements. Additionally, the role involves building study databases and creating study deliverables within established timelines, supporting the development and implementation of study database design modifications, and performing database modifications based on client requirements. The Project Design Manager will monitor assignments, adjust priorities and work schedules to meet deadlines, and complete additional tasks as needed.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.