Data Compliance Specialist at Thermo Fisher Scientific

Warsaw, Masovian Voivodeship, Poland

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Life Sciences, PharmaceuticalsIndustries

Requirements

Understands and adheres to company SOP and COP
Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations

Responsibilities

Study management at the site level
Maintains ISF and study trackers as delegated and verifies that ICFs are correctly completed
Assists with data capturing activities on one or more studies across multiple sites and regions
Ensures accurate and timely entry of all data in the eCRF from the source notes and tracks the flow of the eCRFs and queries
Verifies protocol visit windows are correct according to the protocol requirements and reports deviations
Assists monitors and sponsor representatives with query resolutions after monitoring visits
Assists with input during the review process of SOP and COP
Assists with drafting compliance reports
Assists in archiving procedures
Coordinates frequently with monitors and client representatives
Supports preparation of monitoring visit duties and clarifies any expectations relating to CRFs
Supports audit preparation and audit readiness
Identifies and escalates common data errors and trends and may assist with CAPA and problem-solving methods
Cooperation with Vendors

Skills

eCRF

ICH GCP

ISF

ICF

study management

data entry

query resolution

protocol compliance

audit preparation

CAPA

SOP

data protection

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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