Senior Clinical Trial Manager

2 weeks ago

Plainsboro, New Jersey, United States Genmab Full time
About the Role

We are seeking a highly skilled Senior Clinical Trial Manager to join our team at Genmab. As a key member of our Clinical Operations department, you will be responsible for delivering key trial management elements on oncology trials and ensuring sponsor engagement.

Key Responsibilities
  • Develop operational plans, manuals, and charters for trials
  • Review protocol and protocol amendments, as well as other trial documents
  • Create and coordinate the writing of Investigational Medicinal Product (IMP) Plans
  • Coordinate the development of Trial Oversight Plans
  • Review Clinical Trial Application (CTA) submission packages
  • Review site regulatory documents
  • Develop Global Master Informed Consent Forms
  • Coordinate resolution of site or monitoring issues with CROs or other vendors
Site Selection and Management
  • Drive site selection in collaboration with Start-up
  • Review and approve Site Selection Summary (SSV) documents
  • Coordinate the review of CRO country-specific informed consent forms (ICFs) with internal stakeholders
  • Coordinate translation and back-translation processes for ICFs
Vendor Management and Oversight
  • Oversee vendor management across vendors (excluding budget and change orders)
  • Approve key CRO staff, including Clinical Leads and Trial-specific CRAs
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 ODB review meetings
  • Participate in Risk-Based Quality Management (RBQM) activities
  • Assist in maintaining the CTT issue log with GCTM
  • Collaborate or manage study escalations, both internal and external
  • Support GCTM in assessing KPI/KQI at the trial level
  • Support QA in site audit activities and potential vendor audits
  • Conduct booster visits
  • Participate in inspection readiness activities, as assigned
  • Oversee and collaborate with CTT members, vendors, and assigned functional representatives on tracking and reconciliation of trial-related items, such as scans and blood samples
Requirements
  • Bachelor's or Master's degree in a relevant field, such as medical, biological, pharmaceutical science, or equivalent
  • Minimum 5 years of experience in clinical trial management, preferably from a pharmaceutical company or CRO
  • Experience in oncology and/or first-in-human trials is preferred
  • Proven skills in working in a project-oriented and international organization
  • Excellent communication skills in English, both written and spoken
About You

We are looking for a dedicated team player who enjoys leading teams and inspiring trust among colleagues. You should have a quality mindset, be able to prioritize your work in a fast-paced and changing environment, and be result- and goal-oriented, committed to contributing to the overall success of Genmab.

What We Offer

Genmab offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment, we encourage you to apply.

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