Thermo Fisher Scientific

Project Design Manager I

Kentucky, United States

Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Clinical Research, Laboratory Services, BiotechnologyIndustries

Project Design Manager I

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Location: Remote (US) Environmental Conditions: Office

Position Overview

The Project Design Manager I plays a crucial role within the PPD® Laboratory Services team, directly impacting patient health through scientific expertise. As a key member of the Clinical Research Group / Global Central Labs, this position supports the Project Manager by independently reviewing clinical trial protocols and interpreting Central Lab responsibilities based on protocol definitions and budgeted services. The role involves advising Project Managers on procedural and budgetary matters, as well as system design requirements stemming from database configuration.

Responsibilities

  • 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, sponsor/program requirements, and ancillary supply 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 clients.
  • Works cross-departmentally to ensure study database design meets client and internal requirements.
  • Seeks input and guidance from project design leads and managers when necessary.
  • Builds study databases and creates study deliverables within established timelines under general supervision.
  • Supports the Project Management group with the development and implementation of study database design modifications.
  • Performs database modifications based on client requirements, updating CFC, Kit Specifications, and sample labels as appropriate.
  • Monitors assignments and adjusts priorities and work schedules to meet deadlines and ensure high-quality deliverables.
  • Completes additional tasks as needed to support project, client, and departmental objectives.
  • Understands and follows department working practice documents and SOPs, contributing to their development as needed.
  • Understands and follows appropriate corporate SOPs.

Requirements

  • Education: Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Experience: Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or an equivalent combination of education, training, and experience.
  • Ability to work effectively both independently and as part of a team.
  • Clear communication skills.
  • Strong attention to detail.

Company Information

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders, and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Skills

clinical trial protocols
Central Lab responsibilities
database configuration
laboratory specifications
budget discrepancies
system design requirements
Collection Flow Chart (CFC)
protocol testing requirements
assay volumes
testing location
sample stability
testing frequency
sample allocation
processing instructions
sample disposition
third-party lab requirements
Kit Specifications
study population
assay platform
total allowable blood volume

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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