Sr Safety Committee Specialist - Adjudication

North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Candidates must possess a Bachelor's degree or equivalent qualification and at least 5 years of relevant experience. A thorough understanding of pathophysiology, disease processes, and relevant therapeutic areas is required, along with strong critical thinking, problem-solving, and excellent oral and written communication skills. Proficiency in Microsoft Office Suite and the ability to manage multiple tasks under strict deadlines with limited supervision are also necessary.

Responsibilities

The Sr Safety Committee Specialist will perform day-to-day activities for Clinical Endpoint Committees (CEC) and Data Safety Monitoring Boards (DSMB), including study start-up and close-out. Responsibilities include developing charters, managing member contracts, building electronic adjudication systems, and acting as a liaison between the company, sponsors, and external parties. The role involves reviewing publications to stay updated on regulations, maintaining medical understanding of therapeutic areas, preparing and QCing CEC dossiers, and maintaining secure files for unblinded data. Additionally, the specialist will assist with project implementation, coordination, presentations, and may help prepare departmental procedures and attend audits.

Skills

Clinical Endpoint Committees (CEC)

Data Safety Monitoring Boards (DSMB)

Regulatory Environment

Project Management

Data Management

Biostatistics

Investigator Relations

Vendor Management

Charter Development

Member Contracting

Electronic Adjudication System

Study Start-up

Study Close-out

Sponsor Liaison

Therapeutic Area Knowledge

Disease State Knowledge

Dossier Compilation

Unblinded Data Management

Presentation Skills

Metrics Analysis

Budget Management

Process Improvement

Audit Preparation

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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