Clinical Trial Manager

Genmab

Develop and manage operational plans, charters, and manuals to support trial execution in compliance with regulatory and internal standards. Review of protocol and protocol amendments
Coordinate the development of and manage updates of the Trial Oversight Plan
Review of the Investigator's Brochure from DevOps perspective
Review of the Clinical Trial Application submission package as well as supporting the response to Health Authority questions
Review of Regulatory Green Light packages
Review the Development Safety Update Report
Develop the Global Master ICF 
Act as a key liaison between internal stakeholders and CROs to oversee sponsor oversight visits and ensure quality and compliance across all activities

Collaborate with the CRO and/or internal functions to oversee site selection based on feasibility assessments, aligning site readiness with trial timelines
Coordinate the review of country-specific informed consent forms with internal stakeholders

Monitor and manage vendor deliverables across trial operations, ensuring alignment with trial goals and timelines
Participate in the selection and approval of key CRO personnel, such as Clinical Leads and trial-specific CRAs, to ensure their expertise aligns with trial demands.

Responsible for trial specific protocol deviation guidance and ongoing protocol deviation assessments and trend tracking
Ensure ongoing accuracy and completeness of the eTMF, supporting inspection readiness and regulatory compliance
Maintain relevant sections in Clinical Trial Management Systems and Tools
Drive the Operational Data Base review for the trial
Engage in Risk Based Quality Management activities to enhance data quality and monitoring practices, addressing potential risks proactively
Responsible for maintenance of the Clinical Trial Team issue log in collaboration with Global Clinical Trial Manager
Support GCTM in assessing key performance indicators (KPIs) at the trial level and manage escalation procedures for internal and external stakeholders
Participate in inspection readiness activities, support QA in audit preparations, and conduct site visits as needed
Oversee the tracking and reconciliation of trial-related items, such as scans and blood samples, ensuring trial data accuracy and completeness during trial closeout

Bachelor's or Master's degree with relevant specialization; Master's degree preferred
Minimum requirement: 8+ years in clinical operations
Significant experience leading and managing clinical trials
Experience in leading multiple complex trials, maintenance of trial documentation, CRO engagement, and budget monitoring
Some experience managing/guiding internal (cross-functional) and external (CRO) teams

This role is hybrid and requires 60% in the office

 Experience working in a complex, global and matrixed organization required
Pharmaceutical industry experience with knowledge of ICH/GCP Regulations required
Oncology or TA specific drug development experience and various phases of development preferred
Matrix leadership experience (ability to lead without authority) preferred
Experience mentoring others required
Developing skills in project management and knowledge of tools and processes
End-to-end trial planning and execution knowledge proficient
Developing knowledge in:
- regulatory submissions, metric development and monitoring
- written and verbal communication skills
- negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization
- ability to lead and collaborate with cross-functional teams
- strong trial planning and budget management skills
- strong understanding of clinical trial processes, ICH-GCP regulations, and the clinical drug development lifecycle
Proficient in outsourcing and vendor management
Experience managing trials in global settings, with the ability to oversee complex, multi-regional operations