採用
必須スキル
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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1
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0
模擬応募者数
0
スクラップ
0
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Thermo Fisherについて

Thermo Fisher
PublicThermo 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+
従業員数
Waltham
本社所在地
$200B
企業価値
レビュー
3.0
10件のレビュー
ワークライフバランス
3.5
報酬
3.8
企業文化
3.2
キャリア
3.5
経営陣
2.1
45%
友人に勧める
良い点
Good benefits and compensation
Nice people to work with
Learning opportunities and skill development
改善点
Poor management and leadership issues
Disengaged or unsupportive management
Frequent reorganizations and chaos
給与レンジ
2,092件のデータ
Junior/L3
Mid/L4
Junior/L3 · BUSINESS ANALYST II
1件のレポート
$89,151
年収総額
基本給
$77,501
ストック
-
ボーナス
-
$89,151
$89,151
面接体験
8件の面接
難易度
3.0
/ 5
期間
14-28週間
内定率
12%
体験
ポジティブ 12%
普 通 63%
ネガティブ 25%
面接プロセス
1
Application Review
2
Recruiter Screen
3
Hiring Manager Interview
4
Panel Interview
5
Final Interview
6
Offer
よくある質問
Technical Knowledge
Behavioral/STAR
Past Experience
Culture Fit
Industry Specific
ニュース&話題
Thermo Fisher Scientific launches Applied Biosystems™ PowerFlex™ Thermal Cycler - BioSpectrum India
BioSpectrum India
News
·
3d ago
Ninety One North America Inc. Makes New Investment in Thermo Fisher Scientific Inc. $TMO - MarketBeat
MarketBeat
News
·
3d ago
Ninety One UK Ltd Has $517.14 Million Stock Position in Thermo Fisher Scientific Inc. $TMO - MarketBeat
MarketBeat
News
·
3d ago
Thermo Fisher Scientific Inc. $TMO Stock Holdings Lifted by Ninety One SA Pty Ltd - MarketBeat
MarketBeat
News
·
3d ago