Sr Safety Committee Specialist - Adjudication (Night Shift)

Philippines

Apply with AI Apply

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates should possess an experienced knowledge of procedures and electronic platforms/software systems utilized for direct communications with CEC and/or DSMB committees and other external and pre-existing software systems. Experience with CEC/DSMB study start-up activities including charter development, member contracting, and electronic adjudication system build, as well as close-out activities is required. A medical understanding of applicable therapeutic areas and disease states is also necessary.

Responsibilities

The Sr Safety Committee Specialist will perform day-to-day committee activities for Clinical Endpoint Committees (CEC) and/or Data Safety Monitoring Boards (DSMB) within a highly regulated environment. They will collaborate effectively with project team members, data management, biostatistics, client contacts, investigators, committee members, and third-party vendors. Responsibilities include acting as the company's liaison for CEC/DSMB with the sponsor, assisting project teams in executing CEC/DSMB strategies, reviewing publications to stay updated on regulations and practices, preparing and quality controlling CEC dossier compilations and submissions, and maintaining secure files for DSMB unblinded data. The role also involves assisting with routine project implementation and coordination, preparing departmental and project-specific procedures, and representing specialty committee functions at audits and meetings.

Skills

Clinical Endpoint Committees (CEC)

Data Safety Monitoring Boards (DSMB)

Regulatory Environment

Electronic Adjudication Systems

Project Management

Data Management

Biostatistics

Client Communication

Investigator Communication

Vendor Management

Charter Development

Member Contracting

Study Start-up

Study Close-out

Regulatory Compliance

Therapeutic Area Knowledge

Dossier Compilation

Unblinded Data Management

Audit Preparation

Meeting Presentations

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.

Land your dream remote job 3x faster with AI

Try Jobo Free