Senior Manager, Quality Management
2 settimane fa
Roma, Provincia di Roma; Lazio, Italia
Genmab
Tempo pieno
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At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
The Associate Director, Site Contract Management provides operational leadership to a global team of Site Contract Managers. The role oversees the end-to-end management of Clinical Trial Agreements (CTAs) and other site contracting documents, including negotiation, FMV, and site payments, ensuring compliance with legal and regulatory standards. Acting as a key link between Legal, Compliance, Development Operations and Finance, the position drives contracting efficiency, consistency, and quality. The Associate Director oversees team performance, process optimization, and delivery of timely, audit-ready site contracts that support Genmab’s clinical development objectives. May require occasional domestic and international business travel.
Leadership and People Management
Provides direction and leadership to a team of Site Contract Managers, ensuring effective performance, engagement, and professional development. Oversees resource allocation and prioritization to meet operational needs and foster a culture of accountability, collaboration, and continuous improvement.
Strategic Oversight of Site Contracting
Leads and manages the full lifecycle of Clinical Trial Agreements, including negotiation, FMV benchmarking, execution, and amendments. Drives standardization and efficiency through the implementation of process optimization strategies (e.g. MCTAs) and ensures adherence to global policies, templates, and processes to support timely study start-up.
Legal, Regulatory, and Compliance Alignment
Partners with Legal, Compliance, and Finance to ensure all site contracts meet legal, regulatory and compliance requirements. Maintains audit-ready documentation, proactively identifies risks, and ensures seamless integration of evolving legal and regulatory expectations into daily operations.
Stakeholder Management and Cross-functional Collaboration
Acts as the main escalation point for complex negotiations and fosters strong partnerships with Clinical Operations, Legal, Compliance, and Finance stakeholders. Operational Excellence and Performance Management
Defines and monitors KPIs for site contracting operations to ensure quality, compliance, and timely delivery. Leads continuous improvement initiatives and process optimization while supporting the development of SOPs, tools, and templates to enhance global consistency.
Ensures all contract-related documentation is accurate, complete, and inspection-ready. Supports audits and inspections, drives CAPA implementation, and promotes a strong culture of compliance, quality, and data integrity within the team.
Qualifications/Experience
~ Bachelor's Degree
~10+ years of direct experience in Site Contracting, FMV Benchmarking, and Site Payment tools and processes within the biotechnology/ pharmaceutical, CRO, or healthcare industry
~3+ years people management experience
~ Substantial knowledge with GCP, ICH, Regulatory, and relevant FDA/EMA guidelines
~ Fluent in spoken and written English
~ Excellent stakeholder management, concise written and verbal communication, ability to influence, clearly communicate and collaborate across an increasingly complex matrix environment. Demonstrate advanced skills in Microsoft Office applications (Excel, Word, PowerPoint, Outlook), SaaS based platform tools and other industry standard programs
Applies Innovation and compliance mindset to process evaluation and improvement
Demonstrates self-awareness and ability to receive and provide constructive feedback for development
You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
You can grapple with the unknown and be innovative
You have experience working in a fast-growing, dynamic company (or a strong desire to)
You work hard and are not afraid to have a little fun while you do so
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard‑working, innovative and collaborative team has invented next‑generation antibody technology platforms and harnessed translational, quantitat