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Clinical Trial Manager

2 months ago

Plainsboro, New Jersey, United States Genmab Full time
Job Description

At Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering 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

We are seeking a Senior Clinical Trial Manager to lead the delivery of key trial management elements on oncology trials and ensure sponsor engagement. The ideal candidate will be driven by ensuring a one-team culture with Contract Research Organizations (CROs) and will excel in contributing to great teamwork and working environment. Join our innovative, hardworking, and ambitious team collaborating in a high-performing and high-pace environment to improve the lives of cancer patients.

Working in Clinical Operations is exciting, intense, challenging, and fun at the same time. The dedication, collaborative, and spirited nature of our employees are what really shapes our team. From day one, the onboarding program ensures that you accomplish trainings, get settled with our IT systems, and team up with your mentor, colleagues, and relevant stakeholders.

Key Responsibilities

The Senior Clinical Trial Manager is accountable for the 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. Data Management, Interactive Response Technology, electronic Response Technology], support site activation and recruitment, support data review/cleaning activities, support Principal Investigator/Investigator's Consent Form 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 Informed Consent Form
  • Coordinate resolution of site or monitoring issues working with CRO or other applicable vendors
Site Selection and Management:

The Senior Clinical Trial Manager will:

  • Drive site selection in collaboration with Start-up
  • Review/approve Site Selection Summary
  • Coordinate the review of the CRO country-specific informed consent forms (ICFs) with internal stakeholders
  • Coordinate translation/back translation process of ICFs
Vendor Management and Oversight:

The Senior Clinical Trial Manager will:

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

The Senior Clinical Trial Manager will:

  • 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 Risk-Based Quality Management (RBQM) activities (as implemented going forward)
  • Assist in maintenance of CTT issue log in collaboration with Global Clinical Trial Manager
  • Collaborate or manage study escalations both internal & external
  • Support Global Clinical Trial Manager to Assess Key Performance Indicators/Key Quality Indicators at the trial level
  • Support Quality Assurance 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

The ideal candidate will possess:

  • Understanding of trial execution (knowledge of the processes, procedures, and principles involved in conducting clinical trials)
  • Experience in clinical drug development & Good Clinical Practice (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 setting
Requirements

The ideal candidate will have:

  • A Bachelor's or Master's degree within the medical, biological, pharmaceutical science, or equivalent
  • Minimum 5 years' experience with clinical trial management from a pharmaceutical company and/or Contract Research Organization (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

The ideal candidate will also meet the following personal requirements:

  • Dedicated team player who enjoys leading teams and inspires trust among colleagues
  • Quality mindset and able to prioritize work in a fast-paced and changing environment
  • Result- and goal-oriented and committed to contributing to the overall success of Genmab