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!

TRIAL EXECUTION AND MONITORING

• Conduct initial Protocol Deviation (PD) assessments and track trends
• Ensure the ongoing completeness of the electronic Trial Master File (eTMF)
• Keep the Trial Management Dashboard (TMD) and portfolio app in GenSense up to date
• Drive the ODB review meeting
• Participate in RBQM activities (as implemented going forward)
• Assist in maintenance of CTT issue log in collaboration with GCTM
• Collaborate or manage study escalations both internal & external
• Support GCTM to Assess KPI/KQI at the trial level
• Support QA in site audit activities and potentially vendor audits (supporting with trial information and collection and providing of relevant trial documents)
• Conduct booster visits
• Participate in inspection readiness activities as assigned
• Oversee and collaborate with CTT members/vendors/assigned functional representatives on tracking and reconciliation of trial related items such as scans, blood samples etc.

Additional Job Description

• Lead the cross-functional trial-specific Clinical Management Team (CMT), including the CROs, to deliver clinical trials within budget and timelines and according to quality standards defined by regulations, Genmab SOPs and ICH-GCP
• Engage with internal and external stakeholders to drive collaboration and coordination for trial progress
• Participate in CRO selection, scope of work definition, and ongoing management for assigned trials
• Ensure escalations are made as appropriate to secure proper progress and quality of the trial
• Participate in audits and inspections as required and drive timely response
• Update and maintain trial budgets, including forecasting, accruals and invoice management
• Proactively lead risk management assessment of the conduct of the trial related to patient safety and data integrity

For US based candidates, the proposed salary band for this position is as follows:
$113,840.00-$170,760.00
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.
Regular full-time U.S. employees are eligible to enroll in Genmab benefits. Our benefits package is crafted to help employees feel supported and cared for in all aspects of life — physical, financial, social, and emotional.