At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

Senior Clinical Trial Manager

Are you looking for an opportunity where you can take the lead in delivering key trial management elements on oncology trials and ensure sponsor engagement? We a looking for a Senior Clinical Trial Manager driven by ensuring a one-team culture with CROs and who excels in contributing to great teamwork and working environment. Join our innovative, hardworking, and ambitious team collaborating in a high performing and high pace environment toimprove the lives of cancer patients.

Working in Clinical Operations is exciting, intense, challenging, and fun at the same time. The dedication, collaborative and knock-your-socks-off spirit of our employees are what really shapes our team. From day one, the onboarding program makes sure that you accomplish trainings, get settled with our IT systems and that you team up with your mentor, colleagues, and relevant stakeholders.
Responsibilities
The Sr Clinical Trial Manager is accountable for delivery of selected and/or regional activities within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g. DM, IRT, eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development).

The principal responsibilities are :
Develop operational plans, manuals and charters for the trial Review protocol and protocol amendments and other trial documents as necessary Create and coordinate the writing of Investigational Medicinal Product (IMP) Plan Coordinate the development of the Trial Oversight Plan Review the Clinical Trial Application (CTA) submission package Review site regulatory documents Develop Global Master ICF Coordinate resolution of site or monitoring issues working with CRO or other applicable vendors

Site Selection and Management:
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


Vendor Management and Oversight:
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)


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 issuelog in collaboration with GCTM
Collaborate or manage study escalations both internal & external
Support GCTM toAssess 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.


Key Competencies
Understanding of trial execution (knowledge of the processes, procedures, and principles involved in conduction clinical trials)
Experience in clinical drug development & GCP
Role model the Genmab ONE team spirit
Excellent written and oral English communication skills
Ability to proactively identify risks, develop mitigations, & resolve issues
Stakeholder management both internal and external
Ability to escalate issues as appropriate to internal or external stakeholders
Experience with operating in a Global settings


Requirements
A BSc or MSc level within the medical, biological, pharmaceutical science or equivalent.
Minimum 5 years' experience with clinical trial management from a pharmaceutical company and/or CRO.
Experience within the field of oncology and/or first in human trials is preferred.
Proven skills from working in a project oriented and international organization.
Excellent communication skills in English both written and spoken.


Moreover, you meet the following personal requirements:
Dedicated team player who enjoys leading teams and inspire trust among colleagues.
Quality mindset and able to prioritize your work in a fast paced and changing environment.
Result- and goal-oriented and committed to contributing to the overall success of Genmab.


For US based candidates, the proposed salary band for this position is as follows:

$114,375.00---$190,625.00

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.

About You
You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
You...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity