Senior Manager, Clinical Compliance

  • Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Senior Manager, Clinical Compliance

Job Number: 36517

Location: , 

Job Description

An oncology-focused biotech is seeking a Senior Manager, Clinical Compliance to support trial compliance and training across all stages of development. The ideal candidate will apply global compliance regulations to clinical programs and collaborate with internal teams, vendors, and sites. This role requires a solution-oriented mindset to ensure processes, standards, and training are effective and aligned with team needs. Reports to the Director of Clinical Compliance.

Responsibilities

  • Partner with cross-functional teams to ensure clinical trials align with global regulatory standards, ICH/GCP guidelines, and internal processes.

  • Review study materials, workflows, and outputs to assess compliance, offering recommendations for remediation, training, and process improvements.

  • Address compliance-related inquiries, stay current with regulatory changes, and contribute to the evolution of best practices.

  • Lead or support quality risk management activities, including identifying and addressing risks or trends within clinical operations.

  • Contribute to issue investigations, root cause analyses, and CAPA development and tracking in collaboration with quality teams.

  • Support internal audit planning, participate in site visits, and assist with regulatory inspection readiness and response.

  • Monitor and report on key quality and risk indicators, while promoting a culture of quality and continuous improvement.

  • Perform additional compliance-related responsibilities as needed.

Required Skills

  • Bachelor's degree in life sciences or related field

  • 5+ years of clinical research experience with a focus on compliance

  • Strong understanding of GCP/ICH and relevant regulations

  • Skilled in identifying process improvements and driving change

  • Effective communicator with strong organizational abilities

  • Proven ability to build cross-functional relationships

  • Comfortable working in a fast-paced environment

  • Proficient in Microsoft Office and related tools

 

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