Data Compliance Specialist at Thermo Fisher Scientific

Birmingham, England, United Kingdom

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Clinical Trials, Healthcare, PharmaceuticalIndustries

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
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 and 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 and 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

Skills

Key technologies and capabilities for this role

ISFeCRFGCPICHSOPCOPdata entryquery resolutionprotocol compliancedata protection

Questions & Answers

Common questions about this position

What is the work arrangement or location policy for this role?

This is a full-time position with a standard Monday-Friday work schedule in an office environment.

What qualifications and experience are required for the Data Compliance Specialist role?

A high school diploma or equivalent with relevant qualifications is required, along with previous experience comparable to at least 2 years that provides the necessary knowledge, skills, and abilities.

What key skills are needed for this position?

Candidates need the ability to multi-task and support multiple studies, good interpersonal and excellent communication skills, basic MS Office and computer skills, ability to learn basic medical terminology, and good attention to detail.

What is the company culture like at Thermo Fisher Scientific or TrialMed?

The company emphasizes a team-oriented environment with over 100,000 colleagues sharing values of Integrity, Intensity, Innovation, and Involvement, focused on accelerating research, solving scientific challenges, and supporting patients.

What makes a strong candidate for this Data Compliance Specialist position?

Strong candidates will have at least 2 years of relevant experience, excellent attention to detail, strong communication and interpersonal skills, and the ability to multi-task across multiple studies while adhering to regulations like ICH GCP.

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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