[Remote] Clinical Affairs, Senior (Study Operations) - Transplant Diagnostic at Thermo Fisher Scientific

Indiana, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Bachelor's degree in Science
At least 5 years of hands-on involvement in clinical research
Strong history of effectively managing budgets for clinical trials
Strong knowledge of Good Clinical Practices (GCP), FDA, and EU regulations
Current industry practices related to the conduct of clinical trials
Excellent communication and interpersonal skills
Organized and attentive to detail
Strong analytical and problem-solving abilities
Proficient in applying tools for managing clinical trials (e.g. eTMF, EDC)

Responsibilities

Manage overall clinical study budgets
Negotiate and manage budgets with clinical sites, vendors, and CROs
Support department leadership to determine resource allocation and financial forecasting for clinical studies
Interact with investigative sites, vendors, and other functional areas to ensure successful execution of clinical studies
Coordinate the planning of clinical studies to ensure deliverables are completed on time and within budget
Develop and lead internal clinical project database
Update and/or generate internal Standard Operating Procedures (SOPs) to ensure GCP compliance
Support clinical study management activities, including IRB/EC submission and approval activities
Generate clinical site documentation in compliance to trial protocols
Participate on cross-functional core project teams to ensure clinical deliverables are aligned with Business objectives

Skills

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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