Instagram
youtube
Facebook

Clinical Research Manager

2+ years
Not Disclosed
10 Oct. 30, 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

Company Overview

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

Position Overview

The Clinical Research Manager (CRM) is accountable for the execution and oversight of local operational clinical trial activities. This role is critical in ensuring local regulatory and financial compliance at the country operations level, adhering to ICH GCP and local regulations. The CRM significantly impacts a country’s ability to meet trial commitments and objectives, especially during study execution.

As a customer-facing role, the CRM will build business relationships and represent Fortrea with investigators, functional outsourcing partners, and other external stakeholders. This position requires the ability to make independent decisions and oversee important clinical research activities in alignment with global policies, supported by the Country Research Director or Therapeutic Director.

Key Responsibilities

  • Oversee local clinical trial operations, ensuring adherence to regulatory and compliance requirements.
  • Build and maintain professional relationships with investigators and external partners.
  • Ensure the effective conduct of clinical studies while meeting local regulatory standards.
  • Collaborate and lead high-performing cross-functional teams, including virtual teams.
  • Coordinate training and compliance needs for local teams.
  • Monitor and report on country commitments, ensuring alignment with operational objectives.

Qualifications

Minimum Required:

  • University/college degree in life sciences or certification in a related health profession from an accredited institution (e.g., nursing, medical, or laboratory technology).
  • Alternatively, a minimum of four (4) years of relevant clinical research experience in the pharmaceutical or CRO industries or healthcare settings may be considered.

Experience:

  • Minimum of six to eight (6-8) years of clinical research experience.
  • Strong organizational and time management skills.
  • Working knowledge of ICH, FDA, local regulatory requirements, and IRB/IEC guidelines.
  • Excellent communication skills, both oral and written.
  • Self-motivated with the ability to work under pressure and meet deadlines.
  • Detail-oriented and capable of multi-tasking.
  • Proficient with various computer applications.

Join Us

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for 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 thrive in a collaborative environment that nurtures personal growth and enables you to make a meaningful global impact.

Equal Opportunity Employer

Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in our workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, gender, sexual orientation, age, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.