Senior Manager, External Data Quality Manager

This a Full Remote job, the offer is available from: United States At Genmab, we are dedicated to building extra[not]ordinary 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. Does this inspire you and feel like a fit Then we would love to have you join us! The Role: As a (Senior) Manager in External Data Quality Management (Contractor), you will play a critical role within our Clinical Data Management team, primarily responsible for overseeing the quality and reconciliation of external data provided by third-party vendors, such as laboratories, eCOA providers, and technology vendors. Your expertise will be pivotal in integrating external data into clinical trial databases while ensuring the highest standards of data accuracy and consistency across all studies. Responsibilities: Oversee and ensure the quality of data provided by external third-party providers. Coordinate with internal stakeholders and external partners to optimize data collection strategies to meet trial analysis, reporting, and research needs. Develop and execute study-specific data reconciliation plans in collaboration with Data Management (DM) and Clinical Research Organizations (CROs). Manage third-party vendors and central labs, including conducting performance reviews, resolving issues, and spearheading process improvement initiatives. Ensure timely and accurate delivery of external data, managing timelines and project deliverables effectively. Support process improvements and foster knowledge sharing within the data management teams. Requirements: Bachelors degree in science or related field. Minimum of 5 years of experience in external data management, with extensive experience in third-party vendor management and data oversight. Experience in clinical data management within a clinical research environment, preferably including oncology trials. Proficiency in data reconciliation processes and a thorough understanding of various data types, testing methodologies, and biomarker testing specific to oncology trials. Exceptional project management and communication skills, with the ability to work collaboratively in a multidisciplinary environment. Strong organizational, analytical, and problem-solving skills, with the ability to work independently and thrive in a dynamic, fast-paced environment. Familiarity with clinical trial data systems, Electronic Data Capture (EDC), and related applications is preferred. In-depth knowledge of clinical trials, drug development processes, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), regulatory requirements, and Good Data Management Practices. Additional Job DescriptionAdditional Job Description Trial Clinical Data Mgmt. Act as the point of contact for DM activities for a trial, provide oversight of data collection and management per regulatory and industry standards Provide oversight of the DM CRO and ensure performance against key indicators Create the Data Review and Cleaning Plan; provide DM insight into data cleaning strategy; provide oversight of the data validation plan Review CRFs to ensure alignment with protocol. Lead and perform sponsor acceptance testing of the eCRF. Ensure database structure meets expectations Perform data quality checks and take action to ensure data quality Provide oversight of key DM documentation and inspection readiness of documentation; ensure documentation is aligned with best DM practices Provide DM oversight of data releases/DBLs to ensure quality data is ready for analysis and reporting Contribute to continuous process improvement in DM through suggestions and delivering on assigned tasks Specialist Data Mgmt. Act as the point of contact for start-up DM activities for trials Provide oversight of the DM CRO and ensure planning, coordination of DM start-up activities and timely delivery of high-quality clinical database Provide input to trial design, protocols and amendments to ensure protocol enables proper data collection to support analysis and reporting Gather data collection requirements from stakeholders for EDC/other applications that collect clinical trial data Ensure eCRF/DTS specifications are aligned with industry standards, CDISC requirements and company clinical data