Clinical Trial Manager

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At Genmab, we are dedicated to building extraordinary futures by developing antibody products and groundbreaking 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 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.

The Clinical Trial Manager (CTM) is accountable for delivery of selected and/or regional deliverables within a trial, such as managing vendor deliverables, collaborating with functions to set up activities, supporting site activation and recruitment, data review/cleaning, and PI/ICF development. Scope of responsibilities depends on number of patients, sites and size of trial.

• Develop operational plans, manuals and charters for the trial
• Review protocol and protocol amendments
• Create and coordinate the writing of Investigational Medicinal Product (IMP) Plan
• Coordinate the development of the Trial Oversight Plan
• Review the Investigator's Brochure (IB) from Dev Ops perspective
• Review the Clinical Trial Application (CTA) submission package
• Review Regulatory Green Light (RGL) packages in accordance with QDOC-08903
• Review the Development Safety Update Report (DSUR)
• Develop Global Master ICF
• Follow up on Trial Oversight identified findings during Oversight until closure

• Drive site selection in collaborate with Start-up
• Review/approve SSV summary
• Coordinate the review of the CRO country-specific informed consent forms (ICFs) with internal stakeholder
• Coordinate translation/back translation process of ICFs

• Oversee vendor management across vendors (does not include budget/change orders)
• Approve key CRO staff e.g., Clinical leads, or Trial specific CRA (not including CRAs part of the partnership dedicated model which is managed via Oversight Manager)

• 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 Gen Sense 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.

• Lead the cross-functional trial-specific Clinical Management Team (CMT), including the CROs, to deliver clinical trials within budget and timelines 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 $ – $. The actual salary offer will be based on a range of factors including skills, qualifications, experience and location.

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits:
  
  Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans:
  Critical illness, accident, and hospital indemnity insurance
• Time Off:
  Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources:
  Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks:
  Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous…