Project Design Manager at Thermo Fisher Scientific

Suzhou, Jiangsu, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Life Sciences, PharmaceuticalsIndustries

Requirements

Ability to independently review clinical trial protocols and interpret Central Lab responsibilities based on protocol definitions and budgeted services
Skill in advising Project Managers on procedural and budgetary items and the necessity for change due to database configuration requirements
Capability to support Project Managers in reviewing draft laboratory specifications documents for consistency with protocol and budgeted requirements, and providing feedback on discrepancies, system design requirements, and concerns
Ability to work on a team as well as independently, while maintaining clear communication and attention to detail
Experience ensuring consistency of database design across sponsors and/or programs
Under general supervision and guidance from project design leads and managers, ability to build study database and create study deliverables within established timelines and contracts
Skill in monitoring assignments, adjusting priorities and work schedule to meet deadlines, and providing high quality deliverables

Responsibilities

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 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 and internal requirements
Seeks input and guidance from project design leads and managers when necessary
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
Completes additional tasks as needed to support project, client, and departmental objectives
Understands and follows department procedures

Skills

Clinical Trial Protocols

Protocol Review

Budget Management

Laboratory Specifications

Database Configuration

Project Management

System Design

Clinical Research

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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