Job Information
Genmab Contractor - Senior Clinical Data Manager in Princeton, New Jersey
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:
As a Contractor, Senior Clinical Data Manager, you will act as the point of contact for Data Management (DM) activities for multiple trials,provide oversight of data collection and management per regulatory and industry standards . The Contractor will provide oversight of the DM CRO, ensure performance against key indicators, and provide DM expertise to trial teams .
Key Responsibilities:
Lead 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 strategy
Review 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 structure
Define and perform data quality checks and take action to ensure data quality
Provide oversight of key DM documentation and ensure inspection readiness; ensure documentation is aligned with best practices and provide improvement recommendations based on DM expertise
Drive DM oversight of data releases/DBLs and ensure timely delivery of data deliverables in accordance with Genmab SOPs and ICH/GCP;and ensure data quality for analysis and reporting; prepare for regulatory filings and inspections
Drive and support vendor qualification for data management; define/specify scope of work for functional tasks
Support process improvement and knowledge management by participating in or leading task forces/ projects
Requirements:
Bachelor's degree in science or related area
Must have 8 or more years of clinical datamanagement experience in biotech / pharma industry with significant hands-on end-to-end experience in clinical data management practices.
Experience with clinical trials and the drug development process
Significant 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 strategy
Experience and understanding of GCPs, SOPs, regulatory requirements and good data management practices
Project management experience
Experience within oncology trials highly preferred
Experience with CDISC (SDTM) as well as data collection requirements in oncology trials highly preferred
Applicants within the Eastern Time Zone (US) highly preferred
Where you will work
This position will report to the Princeton, NJ USA office and can be remote-based or hybrid (combination of onsite and home-based work).
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.
About Genmab
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.
When you work with us, you'll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.
Our commitment to diversity, equity, and inclusion
We 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...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity