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Associate Clinical Data Manager(Fsp)-Remote

5+ years
Not Disclosed
10 Oct. 16, 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 Title: Associate Clinical Data Manager (Remote)

Company Overview: As a leading global contract research organization (CRO), Fortrea is committed to scientific rigor and boasts decades of clinical development experience. We provide a comprehensive range of clinical development, patient access, and technology solutions to pharmaceutical, biotechnology, and medical device customers across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is dedicated to transforming drug and device development for our partners and patients worldwide.

Position Summary: The Associate Clinical Data Manager will assist and lead operations alongside the Lead Data Manager (LDM). Key responsibilities include developing project documentation, setting up systems, and implementing data validation procedures. The Associate Clinical Data Manager will also support all data management activities, including database lock, to meet client quality expectations, timelines, and budgets.

Key Responsibilities:

  • Collaborate with and report functionally to the Lead DM for studies involving a combination of healthy and patient populations, multi-site coordination, and medium complexity protocols.
  • Serve as a lead data reviewer, performing data operational tasks including data review and query management to ensure adherence to quality standards (both internal and sponsor-specific).
  • Ensure that all allocated projects comply with relevant protocols, Covance global harmonized SOPs, and GCP standards.
  • Work with the LDM to establish study milestone timelines, demonstrating the ability to interpret and follow timelines to achieve on-time deliverables.
  • Assist or lead internal and external data management meetings.

Remote Work: This position is 100% home-based.

Education and Qualifications:

  • Bachelor’s degree in life sciences, health sciences, information technology, or related field preferred. Equivalent experience may be accepted in lieu of a degree.
  • Fluency in English, both written and verbal.

Experience Requirements:

  • 3 to 5 years of data management experience in oncology is required.
  • Rave Lab Admin experience is essential.
  • Experience managing customer concerns and handling Scope of Work and budgets is preferred.
  • Strong knowledge of the clinical trial process, data management, clinical operations, biometrics, and relevant system applications.
  • Proven time management skills and ability to adhere to project productivity metrics and timelines.
  • Ability to work effectively in a team environment, with strong organizational, communication, and interpersonal skills.

Compensation:

  • Pay Range: $85,000 - $100,000 (excluding benefits, bonuses, commissions, or equity).

Benefits: Fortrea offers a comprehensive benefits package to regular full-time or part-time employees working 20 or more hours per week, including medical, dental, vision, life insurance, STD/LTD, 401(K), ESPP, paid time off (PTO), and flexible time off (FTO).

Join Us: Fortrea is seeking motivated problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. Our commitment to revolutionizing the development process ensures the swift delivery of life-changing therapies to patients in need. Join our exceptional team and contribute to making a meaningful global impact.

Equal Opportunity Employer: Fortrea is proud to be an Equal Opportunity Employer. We celebrate 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 (including pregnancy and medical conditions), family or parental status, marital status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all qualified candidates to apply.

For more information about Fortrea, visit www.fortrea.com.