Thermo Fisher Scientific

Project Design Manager

Kentucky, United States

Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

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.

Responsibilities

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.

Skills

Clinical trial protocols
Central Lab responsibilities
Procedural items
Budgetary items
Database configuration
Laboratory specifications
Protocol discrepancies
System design requirements
Teamwork
Independent work
Communication

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

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.

Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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