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Senior Clinical Data Manager

2+ years
Not Disclosed
10 Oct. 29, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Opportunity: Study Manager

Company: Fortrea
Location: [Insert Location]
Job Type: [Insert Job Type]

Company Overview

Fortrea is a leading global contract research organization (CRO) dedicated to scientific rigor and clinical development excellence. We provide a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas, operating in over 90 countries. Our mission is to transform drug and device development for partners and patients worldwide.

Job Summary

As a Study Manager, you will lead studies involving healthy volunteers and patient populations, manage complex protocols, and maintain strong client relationships. You will ensure all deliverables are met on time and in compliance with relevant protocols, SOPs, and GCP standards.

Essential Job Duties

  • Project Leadership: Accountable for all data management (DM) deliverables; provide guidance to DM study teams and review outputs for quality assurance.
  • Timeline Management: Collaborate with Project Managers to develop timelines that meet contracted milestones; communicate with leads across disciplines to coordinate project activities.
  • Team Coordination: Lead internal project team meetings focused on data; work closely with EDC Design, SAS Programming, Statistics, and PK teams to plan and coordinate deliverables.
  • Risk Management: Proactively identify potential risks and communicate strategies to mitigate them, ensuring timely database lock dates.
  • Client Relations: Develop and maintain client relationships, addressing satisfaction surveys and implementing process improvements as needed.
  • Documentation Management: Ensure accurate documentation and procedures are followed upon project completion; maintain vendor and client communication records.
  • Mentorship and Training: Provide leadership and mentorship in DM processes, aiding in team member performance evaluations and career development.
  • SOP Development: Contribute to the writing, review, and updating of SOPs and related documents.

Experience and Qualifications

  • Education: Bachelor’s degree in a relevant field.
  • Experience: Minimum of 8 years in DM, with at least 2 years in sponsor management and 2 years in technical mentoring. Proven experience in customer negotiations and managing scopes of work and budgets.
  • Knowledge: In-depth understanding of clinical trial processes, DM practices, and the regulatory obligations of the CRO industry.
  • Skills: Strong time management, organizational, communication, and interpersonal skills. Ability to work collaboratively and mentor junior team members effectively.
  • Problem-Solving: Constructive, solution-oriented attitude under time constraints and unexpected challenges.

Why Join Fortrea?

At Fortrea, we are committed to overcoming barriers in clinical trials and revolutionizing the development process. Join our exceptional team to thrive in a collaborative environment that supports personal growth and allows you to make a meaningful global impact.


Equal Opportunity Employer

Fortrea is proud to be an Equal Opportunity Employer. We value diversity and inclusion and do not tolerate harassment or discrimination of any kind. Employment decisions are made based on business needs and individual qualifications without regard to race, religion, color, national origin, gender, family status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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