RoleThe Senior Manager, Inspection Readiness - Good Clinical Practice, plays a key role in supporting the Clinical Trial Operations organization by embedding clinical compliance and inspection readiness into clinical trials and service provider oversight. This position is essential for maintaining a high level of clinical trial inspection readiness while ensuring adherence to Good Clinical Practice (GCP) guidelines and applicable regulatory requirements. The individual will also lead process improvement initiatives.
This is an individual contributor role at the Senior Manager level, reporting to the Director, Trial Delivery Team Lead.
ResponsibilitiesTrial Inspection Readiness and Preparation- Design and optimize tools and processes for trial inspection readiness, leveraging digitalization and automation to improve efficiency and compliance.
- Guide study teams in maintaining trial inspection readiness by providing GCP and clinical compliance support, including risk identification, mitigation and monitoring; management of serious GCP breaches and other reportable or non-reportable persistent non-compliance events; and follow-up and closure of quality events, thereby strengthening sponsor oversight.
- Conduct ongoing assessments of compound and/or trial inspection readiness by analyzing key metrics to generate actionable insights.
- Lead the development and delivery of GCP inspection readiness training and tools for Clinical Trial Operations and other key stakeholders.
- Collaborate closely with GCP QA to support the operational framework and inspection setup during sponsor, site and vendor GCP inspections.
- Facilitate lessons-learned activities based on inspection readiness assessments, preparations and outcomes within Clinical Trial Operations.
Quality Events Oversight- Maintain oversight of Clinical Trial Delivery quality events and effectiveness checks, ensuring compliance with applicable requirements.
- Analyze trends in findings from audits, inspections and quality events, as relevant to Clinical Trial Operations and other key stakeholders.
Clinical Compliance- Provide guidance and support on ICH-GCP guidelines, applicable regulatory requirements (e.g., FDA, EMA, MHRA, PMDA and NMPA) and Genmab SOPs.
- Lead and contribute to functional and/or cross-functional business process improvements, system enhancements and innovative initiatives.
Requirements- Bachelor's (BSc) or master's degree (MSc) in Life Sciences, Pharmacy, Medicine or a related discipline.
- A minimum of 8 years of experience in Clinical Operations, Clinical Quality, Inspection Readiness or Clinical Compliance within the pharmaceutical or biotechnology industry.
- Strong understanding of clinical trial processes, ICH-GCP guidelines, applicable regulations and the clinical drug development lifecycle.
- Strong project management skills and knowledge of relevant tools and processes.
- Experience mentoring colleagues and supporting their professional development.
- Excellent written and verbal communication skills.
- Ability to proactively identify risks, develop mitigation strategies and effectively resolve issues.
- Strong stakeholder management skills, with the ability to collaborate effectively across functions in a complex, global, matrix organization.
For US based candidates, the proposed salary band for this position is as follows:
$130,720.00---$196,080.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
- 401(k) Plan: 100% match on the first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
- Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process
