Associate Clinical Data Manager

6-8 years

Not Disclosed

Bangalore

10 Jan. 18, 2025

Job Description

Job Type: Full Time Education: BE/BCS/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: Associate Clinical Data Manager
Location: Bangalore
Category: Data Management & Data Science
Job ID: 2447287

Job Overview

Fortrea is seeking an experienced Associate Clinical Data Manager to lead data management activities on clinical studies, ensuring high-quality data management throughout the lifecycle of the study. This role involves working closely with sponsors, managing scope, and overseeing timelines and budgets. The Associate Clinical Data Manager will be responsible for guiding junior staff, ensuring compliance with protocols, and optimizing processes to deliver quality results.

Key Responsibilities

Leadership & Project Management:
- Lead data management (DM) activities, including study setup, data entry, and validation procedures.
- Provide leadership and direction to the DM study team, ensuring quality and timely deliverables.
- Collaborate with the Project Manager and other functional teams to establish timelines and milestones.
- Track scope changes and work with the Project Manager to ensure Sponsor approval and processing.
Client Interaction & Risk Management:
- Work directly with sponsors to understand their requirements and ensure their needs are met.
- Regularly review and ensure processes remain optimal for both the sponsor and Fortrea.
- Manage risk and mitigation strategies in coordination with other departments to achieve project goals.
Data Management & Reporting:
- Oversee the reconciliation of clinical data against safety, laboratory, and third-party data.
- Lead internal project meetings to discuss progress and ensure data-driven discussions are addressed.
- Address client feedback and concerns, ensuring issues are resolved promptly.
Team Development & Mentorship:
- Mentor junior team members and provide feedback for career development.
- Support DM managers with performance evaluations, interpersonal skills, and achieving competency standards.
Process Improvement:
- Stay updated on new DM technologies and industry trends to improve operational efficiency.
- Contribute to the development and promotion of Biometrics services to sponsors.

Qualifications

Minimum Requirements:
- University or college degree, or equivalent relevant experience.
- Fluent in English (both written and verbal).
Experience:
- 6 to 8 years of experience in data management with at least 1 year in direct sponsor management.
- Experience managing customer concerns and Scope of Work (SOW) and budgets.
- Strong knowledge of the clinical trial process, data management, biometrics, and system applications.
- Excellent time management and organizational skills.
Preferred Qualifications:
- A degree in life sciences, health sciences, information technology, or related fields.
- Experience with Electronic Data Capture (EDC).
- Knowledge of medical terminology and Fortrea's Standard Operating Procedures (SOPs).

Company Overview

Fortrea is a global contract research organization (CRO) dedicated to transforming drug and device development through innovative solutions. With operations across nearly 100 countries, Fortrea works closely with pharmaceutical, biotechnology, and medical device companies to bring life-changing therapies to patients.

Equal Opportunity Employer Statement

Fortrea is an Equal Opportunity Employer committed to diversity and inclusion in the workforce. We do not tolerate discrimination of any kind and encourage individuals of all backgrounds to apply.

Accommodation

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

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Associate Clinical Data Manager

Job Description

Job Overview

Key Responsibilities

Qualifications

Company Overview

Equal Opportunity Employer Statement

Accommodation

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