Clinical Trial Manager

Genmab•Plainsboro Township, NJ

17d

About The Position

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! Overview 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. 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

Requirements

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 collaborator who can work in teams with a broad spectrum of backgrounds
You take pride in enabling the best work of others on the team
You can 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!

Responsibilities

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 DevOps 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 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.
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

Benefits

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

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume