Central Monitoring Manager

10+ years

Not Disclosed

Bangalore

10 Jan. 18, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Central Monitoring Manager
Location: Bangalore
Category: Clinical
Job ID: 2446071

Job Overview

Fortrea is looking for a skilled Central Monitoring Manager to oversee the central monitoring activities across multiple clinical studies. This role involves managing the study portfolio, tracking risk, and applying data to recommend necessary changes. The Central Monitoring Manager will lead the development of risk management strategies, collaborate with project teams, and ensure high-quality monitoring across all phases of the studies.

Key Responsibilities

Central Monitoring Management:
- Oversee central monitoring activities for multiple studies, ensuring accurate tracking and status reporting.
- Act as the point of contact for customers, providing regular updates and managing expectations.
- Lead site, subject, and study level reviews as applicable, supporting less experienced team members.
Risk Management & Reporting:
- Perform site risk assessments and develop site risk stratifications.
- Collaborate in the development of the Risk Management Register and Study Risk Impact Reports.
- Identify critical data and process definitions and ensure they are implemented in the EDC design.
- Develop mitigation strategies for risk factors, including study-specific risk factor definitions and monitoring intervention levels.
- Review ongoing dashboard results, recommend mitigation actions, and ensure identified issues are resolved.
Data Analytics & Review:
- Perform subject clinical reviews and study analytics as per the plans.
- Review and approve changes to monitoring levels to ensure compliance with sponsor needs.
- Oversee quality and risk reports to ensure client satisfaction.
Team Coaching & Process Improvement:
- Coach internal and external project teams to increase competence in central monitoring.
- Contribute to SOP writing, process mapping, and process improvement initiatives using Six Sigma and LEAN methodologies.
- Submit suggestions for improved systems and tools to leadership.

Qualifications

Minimum Requirements:
- University or college degree, or equivalent relevant experience.
- Minimum 10+ years of experience in clinical research, including project management, clinical monitoring, or data management.
Preferred Skills:
- Strong experience with central monitoring activities and risk management.
- Excellent communication, leadership, and organizational skills.

Company Overview

Fortrea is a leading global contract research organization (CRO) with a commitment to transforming the drug and device development process. We operate in more than 90 countries, helping pharmaceutical, biotechnology, and medical device customers bring life-changing therapies to patients.

Equal Opportunity Employer Statement

Fortrea is an Equal Opportunity Employer, dedicated to promoting diversity and inclusion within the workforce. We do not tolerate discrimination and encourage individuals of all backgrounds to apply.

Accommodation

Fortrea offers reasonable accommodations for individuals requiring assistance during the hiring process. For accommodation requests, please contact taaccommodationsrequest@fortrea.com.

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Central Monitoring Manager

Job Description

Job Overview

Key Responsibilities

Qualifications

Company Overview

Equal Opportunity Employer Statement

Accommodation

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