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채용Thermo Fisher

Clinical Compliance Manager

Thermo Fisher

Clinical Compliance Manager

Thermo Fisher

Remote, Mexico

·

Remote

·

Full-time

·

2mo ago

필수 스킬

GCP Compliance

CAPA

Root cause analysis

Regulatory communication

Written communication

Oral communication

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

  • Join Us as a Clinical Compliance Manager
  • Make an Impact at the Forefront of Innovation
    The Clinical Compliance Manager is responsible for the assessment, management, and reporting of serious breaches of GCP and protocol in clinical trials. This role ensures timely escalation, root cause analysis, regulatory communication, and CAPA tracking in alignment with global regulatory requirements (e.g., EMA, MHRA, FDA). The ideal candidate will serve as a subject matter authority on potential serious breach handling and support other activities related to QA across the clinical development portfolio.

What You'll Do:

  • Lead the assessment and classification of serious breaches in collaboration with QA, Clinical Operations, and Regulatory Affairs.
  • Serve as the primary point of contact for serious breach investigations.
  • Prepare and submit serious breach notifications to applicable regulatory authorities within required timelines.
  • Develop and maintain standard operating procedures (SOPs) related to breach management.
  • Ensure timely and thorough root cause analysis and CAPA development, working closely with functional area leads.
  • Maintain breach documentation and logs in compliance with GCP and inspection expectations.
  • Support audits and regulatory inspections as a subject matter expert (SME) for serious breach.
  • Deliver training and guidance to study teams and sites on breach awareness and reporting procedures.
  • Trend and report breach data to identify process improvements or systemic quality issues.

Education & Experience Requirements:

  • Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
  • 5 years of clinical research experience, with at least 2 years in Clinical Quality, GCP Compliance, or related role.
  • Strong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA serious breach expectations.
  • Proven experience in CAPA, root cause analysis, and deviation management.
  • Demonstrated ability to communicate complex compliance issues clearly and effectively.
  • Comfortable working in a matrix organization and managing cross-functional customers.
  • Prior experience with clinical quality systems (e.g., Veeva Vault, Track Wise, etc.) is a plus.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:

  • Thorough knowledge of applicable GxP and appropriate regional regulations
  • Extensive knowledge of the clinical trial process and serious breach reporting
  • Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
  • Training/mentoring experience
  • Strong attention to detail
  • Effectively works independently or in a team environment
  • Highly developed problem solving skills, risk assessment and impact analysis abilities
  • Strong leadership skills
  • Strong organizational and time management skills including ability to multitask and prioritize competing demands/work load
  • Strong digital literacy; ability to learn and become proficient with appropriate software
  • Proven flexibility and adaptability
  • Ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
  • Veeva QMS experience a plus

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

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총 지원 클릭 수

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모의 지원자 수

0

스크랩

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Thermo Fisher 소개

Thermo Fisher

Thermo Fisher Scientific Inc. is an American life science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services.

10,001+

직원 수

Waltham

본사 위치

$200B

기업 가치

리뷰

3.0

10개 리뷰

워라밸

3.5

보상

3.8

문화

3.2

커리어

3.5

경영진

2.1

45%

친구에게 추천

장점

Good benefits and compensation

Nice people to work with

Learning opportunities and skill development

단점

Poor management and leadership issues

Disengaged or unsupportive management

Frequent reorganizations and chaos

연봉 정보

2,092개 데이터

Junior/L3

Mid/L4

Junior/L3 · BUSINESS ANALYST II

1개 리포트

$89,151

총 연봉

기본급

$77,501

주식

-

보너스

-

$89,151

$89,151

면접 경험

8개 면접

난이도

3.0

/ 5

소요 기간

14-28주

합격률

12%

경험

긍정 12%

보통 63%

부정 25%

면접 과정

1

Application Review

2

Recruiter Screen

3

Hiring Manager Interview

4

Panel Interview

5

Final Interview

6

Offer

자주 나오는 질문

Technical Knowledge

Behavioral/STAR

Past Experience

Culture Fit

Industry Specific