Job Information
Genmab Senior Clinical Data Manager (Hybrid or Remote) 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 & Department
As 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.
Key responsibilities include:
The Senior Clinical Data Manager 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.
As a Senior Clinical Data Manager, you will:
Act as the point of contact for DM activities for multiple trials, provide oversight of data collection and management per regulatory and industry standards
Provide oversight of the DM CRO and ensure performance against key indicators; provide DM expertise to trial teams
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; 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 - what is expected of you
Bachelor's degree in science or related area
A minimum of 7-8 years of experience in clinical data management experience in biotech/ pharma industry; Significant hands-on end-to-end experience in clinical data management practices. Experience within oncology trials highly preferred.
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
Experience with CDISC (SDTM) as well as data collection requirements in oncology trials preferred
Experience with Clinical development/trial conduct, including ICH-GCP
Project management experience
Furthermore, the following skills are part of your personal toolbox:
Planning and organizational skills
Team leadership skills
Problem solving and decision-making skills
Excellent written, verbal, and organizational skills
Quality mindset
Document creation and management skills
Process development skills
Being proactive and accountable
Analytical skills with the ability to interpret and present clinical data
Where you will work
This role can be based in Copenhagen, Denmark; or Princeton, NJ USA and is hybrid. Genmab can consider candidates not in commuting distance to our offices for remote.
For US based candidates, the proposed salary band for this position is as follows:
$114,375.00---$190,625.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.
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...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity