Data compliance coordinator at Thermo Fisher Scientific

Wrocław, Lower Silesian Voivodeship, Poland

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification (technical positions may require a certificate)
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years)
Ability to multi-task and support multiple studies with a number of participants simultaneously
Good interpersonal skills
Excellent communication skills with Polish and English
Basic MS Office and computer skills
Ability to learn basic medical terminology
Good attention to detail

Responsibilities

Maintains ISF and study trackers as delegated and supports the verification that ICFs are correctly completed
Assists with data capturing activities on one or more studies (may provide support across multiple sites and/or regions)
Ensures accurate and timely entry of all data in the eCRF from the source notes and helps track the flow of the eCRFs and queries
Assists with the verification that protocol visit windows are correct according to the protocol requirements and reports deviations
May assist monitors and sponsor representatives with query resolutions after monitoring visits (escalates to management as needed)
Learns and adheres to company SOP and COP and assists with input during the review process
Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations
Assists with drafting compliance reports
Data collection and data entry to CRF; track the flow of CRFs, queries and patient recruitment status and ability to report out the flow of data
Set up of project files, ensuring sufficiency and accuracy of versions of appropriate documentation
Assist with producing guidelines for the data entry process for studies
Ensure individual development and continual service improvement; be a Data Coordinator on ongoing projects to assist with the delivery of projects within timelines
Deliver good quality data by ensuring an understanding of source documentation and transcription into CRF
Create good relationship with customers and ensure high level of customer service
Work according to SOP/COPs and GCP guidelines
Perform quality control as described in the relevant procedure and as applicable to the role
Other duties as assigned (e.g., named archives)

Skills

Data Entry

Data Validation

Discrepancy Management

CRF Management

Query Management

Patient Recruitment Tracking

SOP Compliance

GCP Guidelines

Quality Control

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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