(Senior) Manager, External Data Quality Management

The Role

As a (Senior) Manager in External Data Quality Management, you will hold an important role within our Clinical Data Management team. Your primary responsibility will be overseeing the quality and reconciliation of external data delivery by third-party providers such as laboratories, eCOA providers, and technology vendors. This role requires an expert understanding of integrating external data into clinical trial databases, ensuring the highest standards of data accuracy and consistency across all studies.

Responsibilities

• Provide oversight and review of data delivered by third-party external providers, ensuring high-quality data collection and testing services on behalf of Genmab.
• Liaise with internal stakeholders (Biomarker Operations, Data Management (DM), Data Analytics, Medical, Statistics, etc.) and external partners to streamline the data collection strategy, aligning with the trial's analysis, reporting, and exploratory research needs.
• Develop and implement study-specific third-party data reconciliation plans in collaboration with DM CROs.
• Oversee DM CROs for quality reconciliation of external data, ensuring seamless integration into the study database.
• Collaborate with cross-functional teams, external vendors, and DM CROs to resolve data issues efficiently.
• Manage third-party vendors and central labs, including performance reviews, issue resolution, and process improvement initiatives.
• Ensure timely delivery of external data, overseeing timelines and deliverables effectively.
• Support process improvement and knowledge sharing within the data management and external data teams.

Requirements

• Bachelor's degree in science or a related field.
• At least 5 years of experience in external data management, with a strong background in third-party vendor management and external data oversight.
• Clinical data management experience within a clinical research environment (pharmaceutical, biotech, CRO), preferably including oncology trials.
• Proficient in external data reconciliation with a comprehensive understanding of various data types, testing methodologies, and biomarker testing in oncology trials.
• Exceptional project management and communication skills, capable of working collaboratively in a multidisciplinary setting.
• Strong organizational, analytical, and problem-solving abilities.
• Ability to operate independently and as part of diverse teams, thriving in a dynamic, fast-paced environment.
• Familiarity with clinical trial data systems, EDC, and related applications is a plus.
• In-depth knowledge of clinical trials, drug development processes, GCPs, SOPs, regulatory requirements, and Good Data Management Practices.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to 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

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.