Clinical Trial Manager

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!

The Clinical Trial Manager (CTM) is accountable for delivery of selected and/or regional deliverables within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g., Calyx, IRT, eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development). Scope of responsibilities depending on number of patients/sites/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 (until process moved to GDS responsibility expected Q4/ end October after this date responsible for co-authoring only )
• 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

• Drives 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 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…