Thermo Fisher Scientific
Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics
Project Design Manager
September 20
Thermo Fisher Scientific
Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics
Description
• Understands and follows department's working practice documents and SOPs, and supplies to their development as needed, as well as understands and follows appropriate corporate SOPs. • Ensures consistency of database design across sponsors and/or programs. • Configures Collection Flow Chart (CFC) based on protocol testing requirements, assay volumes, testing location, sample stability, and frequency of testing. • Determines appropriate testing to sample allocation based on testing schedule, processing instructions, sample disposition, and third-party lab requirements. • Configures Kit Specifications based on protocol testing requirements, assay volumes, testing schedule, testing location, sample stability, testing frequency, study population, assay platform, total allowable blood volume, and sponsor/program requirements, as well as determining ancillary supply requirements based on matrices, time points, study population, and collection device requirements. • Configures sample labels based on client needs and collection requirements. • Attends internal and external meetings and teleconferences; provides Project Manager support during laboratory specifications development discussions with client. • Works cross-departmentally to ensure study database design meets client needs, as well as internal requirements. • Under general supervision and guidance from project design leads and managers, builds study database and creates study deliverables within the timelines established by the team and indicated by the contract. • Supports Project Management group with the development and implementation of study database design modifications. • Performs database modifications based on client requirements; updates CFC, Kit Specifications, and sample labels, as appropriate, based on database modifications. • Adjusts priorities and work schedule to meet deadlines and provide high-quality deliverables.
Requirements
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience. • Good interpersonal skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines • Effective project management skills • Good digital literacy • General knowledge of clinical trial processes and programs • Strong attention to detail and problem-solving skills • Good written and verbal communication skills • Ability to effectively conduct oral presentations • Demonstrated experience in identification and resolution of technical problems in a professional environment • Ability to maintain a high degree of confidentiality with clinical teams • Demonstrated positive attitude, enthusiasm toward work, and the ability to work in a team
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