Senior Clinical Data Manager

Genmab

Danmark
Kontrakt
Fuldtid

1 måned siden

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.The Role & DepartmentAs the Senior Clinical Data Manager, you will be operationally responsible for tasks within the planning, start-up, conduct and closure of clinical trials from final synopsis and/or a Clinical Trial Team (CTT) is assigned.The Senior Clinical Data Manager will represent Clinical Operations Data Management on the CTT, and with partners and/or Data Management/Statistical vendors. You may support the overall strategy and development of Clinical Operations by participating in task force initiatives within the department.This role can be located in Copenhagen, Denmark, or Utrecht, the Netherlands, or Princeton, New Jersey, U.S., and is hybrid.Key responsibilitiesYou will be part of the cross-functional trial specific CTT and be responsible for core deliverables such as clinical database design/setup, data collection, data validation, manual review, and timelines. All activities will be performed according to quality standards defined by regulations/standards, Genmab SOPs and ICH-GCP.Act as the point of contact for DM activities for multiple trials, provide oversight of data collection and management per regulatory and industry standardsProvide oversight of the DM CRO and ensure performance against key indicators; provide DM expertise to trial teamsLead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy.Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategyReview CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structureDefine and perform data quality checks and take action to ensure data qualityProvide oversight of key DM documentation and ensure inspection readiness; ensure documentation is aligned with best practices and provide improvement recommendations based on DM expertiseDrive DM oversight of data releases/DBLs and ensure timely delivery of data deliverables in accordance with Genmab SOPs and ICH/GCP; ensure data quality for analysis and reporting; prepare for regulatory filings and inspectionsDrive and support vendor qualification for data management; define/specify scope of work for functional tasksSupport process improvement and knowledge management by participating in or leading task forces/ projectsRequirementsBachelor's degree in science or related area5-8+ years of experience in clinical data management experience in biotech/ pharma industry; significant hands-on end-to-end experience in clinical data management practicesExperience within oncology trials highly preferredExperience with clinical trials and the drug development processSignificant experience leading data management activities for multiple clinical trials; proficient use of data management systems; advanced knowledge of DM processes, tools, methodologies and documentation; strong understanding of DM strategyExperience and understanding of GCPs, SOPs, regulatory requirements and good data management practicesExperience with CDISC (SDTM) as well as data collection requirements in oncology trials preferredProject management experienceFurthermore, the following skills are part of your personal toolbox:Planning and organizational skillsTeam leadership skillsProblem solving and decision-making skillsExcellent written, verbal, and organizational skillsQuality mindsetDocument creation and management skillsProcess development skillsBeing proactive and accountableAnalytical skills with the ability to interpret and present clinical dataAbout 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

LocationsGenmab 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.About GenmabGenmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.Our commitment to diversity, equity, and inclusionWe are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on .Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website .Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Genmab

Ansøg nu