Clinical Compliance Manager - Serious Breach

United Kingdom

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates must possess a Bachelor's degree in life sciences, nursing, pharmacy, or a related field, with a minimum of 5 years of clinical research experience, including at least 2 years in Clinical Quality, GCP Compliance, or a similar role. A strong understanding of ICH E6(R2/R3), EMA/MHRA/FDA serious breach expectations, proven experience in CAPA, root cause analysis, and deviation management, and demonstrated ability to communicate complex compliance issues effectively are essential. Experience in a matrix organization and familiarity with clinical quality systems like Veeva Vault or TrackWise are considered advantageous.

Responsibilities

The Clinical Compliance Manager will lead the assessment and classification of serious breaches in clinical trials, acting as the primary contact for investigations and preparing notifications to regulatory authorities. This role involves developing and maintaining SOPs for breach management, ensuring thorough root cause analysis and CAPA development, and maintaining compliant breach documentation. The manager will also support audits and inspections as an SME, deliver training on breach procedures, and trend breach data to identify areas for process improvement.

Skills

GCP

Clinical Trials

Regulatory Affairs

Root Cause Analysis

CAPA

SOP Development

Quality Assurance

EMA

MHRA

FDA

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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