Central Monitoring Manager
Location: Bangalore
Category: Clinical
Job ID: 2446074
Company: Fortrea
Company Overview
Fortrea is a leading global contract research organization (CRO) that provides pharmaceutical, biotechnology, and medical device clients with clinical development, patient access, and technology solutions. With operations in ~100 countries, we are transforming drug and device development for partners and patients worldwide.
Role Overview
The Central Monitoring Manager will be responsible for overseeing central monitoring activities across multiple studies, managing risk assessment, and ensuring compliance with regulatory and operational standards. The role involves data-driven decision-making, risk-based monitoring strategies, and collaboration with internal and external stakeholders.
Key Responsibilities
Central Monitoring & Risk-Based Monitoring (RBM) Implementation
Oversee central monitoring activities for multiple studies, ensuring accurate tracking and reporting.
Serve as the primary customer point of contact for a portfolio of studies.
Develop and implement Central Monitoring Plans and risk-based strategies.
Perform site, subject, and study-level data reviews, identifying and mitigating risks.
Support the initial Risk Management Register and coordinate the Site Risk Assessment process.
Ensure Critical Data & Process Definition are implemented in the Electronic Data Capture (EDC) system.
Conduct site risk stratifications, propose baseline site risk levels, and recommend monitoring interventions.
Data Analytics & Risk Mitigation
Define prescriptive risk factor mitigation strategies, including Source Data Verification (SDV) strategies.
Configure tools, program study-specific risk factors, and perform User Acceptance Testing (UAT).
Conduct dashboard reviews and data analytics assessments to identify trends and risks.
Recommend and implement risk mitigation actions, escalating issues when necessary.
Ensure continuous process improvements using Six Sigma and LEAN methodologies.
Project Management & Compliance
Oversee Project Quality and Risk Reports, ensuring compliance with study requirements.
Lead bid defense meetings and sponsor presentations, supporting business development activities.
Contribute to Standard Operating Procedures (SOPs), process mapping, and optimization initiatives.
Provide coaching and mentorship to project teams to enhance central monitoring competency.
Required Qualifications & Experience
Education:
Bachelor’s or Master’s degree from an accredited institution in Life Sciences, Pharmacy, Medicine, or a related field.
Equivalent relevant experience may be considered in lieu of educational requirements.
Experience:
Minimum 10 years of experience in clinical research, risk-based monitoring, or central monitoring within a pharmaceutical company, CRO, or equivalent industry.
Experience in clinical trial operations, project management, data management, and informatics.
Expertise in risk assessment, site monitoring, and study analytics.
Strong knowledge of global regulatory requirements (ICH-GCP, FDA, EMA) and RBM methodologies.
Skills & Competencies:
Strong analytical and problem-solving skills for risk-based decision-making.
Proficiency in clinical trial data analytics tools and risk monitoring platforms.
Excellent stakeholder management, communication, and leadership abilities.
Experience in process improvement methodologies (LEAN, Six Sigma) is an advantage.
Ability to work in a fast-paced, global environment with cross-functional teams.
About Fortrea
Fortrea is committed to advancing clinical trials and patient access through scientific innovation. We foster a collaborative and inclusive work environment where professionals can make a global impact.
Equal Opportunity Employer Statement
Fortrea is an Equal Opportunity Employer (EOE/AA) that fosters diversity and inclusion. We do not discriminate based on race, religion, gender, disability, veteran status, or any other legally protected characteristic.
For more details, visit www.fortrea.com.
If you require accommodations during the hiring process, please contact taaccommodationsrequest@fortrea.com.
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