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Associate Clinical Data Manager

6-8 years
Not Disclosed
10 Feb. 6, 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

Associate Clinical Data Manager

📍 Location: Bangalore, India
🗓️ Category: Data Management & Data Science
🆔 Job ID: 2447287

About Fortrea:

Fortrea is a leading global contract research organization (CRO) dedicated to improving drug and device development. With operations in approximately 100 countries, Fortrea provides services in clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

Job Overview:

As an Associate Clinical Data Manager at Fortrea, you will be responsible for the leadership and management of data management activities on clinical trials, overseeing everything from study set-up to database lock. You will work directly with Sponsors, ensuring that all requirements are met within timelines and budgets, while also leading and mentoring junior staff.

Summary of Responsibilities:

  1. Data Management Leadership:

    • Lead clinical data management (DM) activities across studies, ensuring that the team follows protocols, SOPs, and GCPs.
    • Organize workloads, prioritize deliverables, and meet timelines.
    • Manage and ensure data validation and entry procedures are followed.
    • Collaborate with project managers and other team leads to coordinate timelines and ensure timely delivery.
  2. Client and Stakeholder Management:

    • Develop and maintain strong client relationships and handle client communications effectively.
    • Track scope changes, ensuring sponsor approval is obtained.
    • Provide leadership in project management and internal team meetings to ensure alignment.
  3. Mentorship and Team Leadership:

    • Provide guidance and mentorship to DM staff, offering feedback to aid career development.
    • Ensure all team members meet competency standards.
  4. Risk Management and Quality Assurance:

    • Proactively identify risks and mitigation strategies to ensure project success.
    • Ensure all deliverables are of the highest quality by reviewing work outputs from the team.
  5. Other Responsibilities:

    • Lead audits and resolve any issues identified during audits.
    • Promote Fortrea's biometrics services to sponsors.
    • Manage client satisfaction and provide updates on project status.

Minimum Qualification Requirements:

  • University/college degree or relevant experience equivalent.
  • Fluent in English (written and verbal).
  • 6-8 years of experience in data management with at least 1 year of direct sponsor management.

Preferred Qualifications:

  • Degree in life sciences, health sciences, or a related field.
  • 3+ years of Electronic Data Capture (EDC) experience.
  • Thorough understanding of Fortrea's structure and Standard Operating Procedures (SOPs).

Work Environment:

  • Office and home-based work.
  • Flexibility in working hours, including possible overtime and weekend shifts.

Why Join Fortrea?

Fortrea fosters a collaborative, dynamic environment where problem-solving and creative thinking are valued. You will have the opportunity to be part of an organization that strives to revolutionize clinical trials and contribute to life-changing therapies.

Equal Opportunity Employer:

Fortrea is committed to diversity, inclusion, and equal employment opportunities. We do not tolerate any form of discrimination and make hiring decisions based on business needs and individual qualifications.

How to Apply:

Interested candidates can apply directly via Fortrea’s careers website.