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Parexel logo
Parexel

Parexel is an international biopharmaceutical services organization offering a comprehensive range of solutions to the biotechnology, pharmaceutical, and medical device industries.

Clinical Compliance Manager

Location

United States

Posted

20 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Clinical Compliance Manager

Parexel

• Provide quality leadership and direction to sponsor R&D stakeholders on GCP-related activities/issues and act as GCP expert/consultant for R&D colleagues. • Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas. • Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed. • Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness). • Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches. • Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies. • Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues. • Participate in vendor evaluations as a Subject Matter Expert (SME) as needed. • Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings. • Provide support and guidance for sponsor Quality Management System activities including self-reporting deviations, root cause analysis, and CAPA plan development and evaluation. • Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion. • Maintain a high level of expertise in international GCP regulations and internal Policies and Procedures that may impact drug development. • Provide support and guidance during and following internal audits and external regulatory inspections (as required). • Provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities. • Lead / manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections.

Job Requirements

  • Bachelor’s degree is required, life science or related discipline preferred.
  • Minimum of 5 years in CRO, pharmaceutical or biotechnology industry experience, with 3+ years in a GCP clinical compliance, quality assurance, or regulatory compliance role.
  • Thorough knowledge and understanding of drug development and the clinical trial process.
  • In-depth knowledge of current regulatory and ICH GCP requirements and experience with international regulations, guidelines and standards is required.
  • Working knowledge of CAPA management, risk management, regulatory inspections and GLP requirements is a plus.
  • Excellent written and verbal communications skills with the ability to influence others and gain commitment.
  • Ability to work in an entrepreneurial and fast-paced culture.
  • Must be disciplined, detail-oriented, and able to multitask and work efficiently and independently.
  • Ability to collaborate and partner with various internal business partners.
  • Ability to work in a team environment.
  • Highly developed problem-solving skills and the ability to resolve difficult conflicts.

Benefits

  • Health insurance
  • Flexible working arrangements

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