Lead end-to-end trial execution activities from start-up to close out
Gather and maintain up-to-date project and trial information to support the execution of clinical drug supply strategies
Ensure timely planning, execution, and delivery of clinical trial supplies in alignment with study milestones and program strategy
Maintain all trial level inventory and ensuring no stock out situations
Actively participate in Clinical Trial Team (CTT) activities and meetings and other cross-functional forums to ensure aligned planning and execution
Early identification of risks and potential delays related to drug supply, inventory, or timelines, and develop mitigation and contingency plans
Participate in regulatory discussions in relation to IMP/AxMP
Manage and maintain project/trial specific documentation (i.e. Trial Notification File (TNF), IMP manual, SIV slides, filing in eTMF etc.)
Budget forecasting throughout the trial lifecycle
Ensure GxP & regulatory guideline compliance during all drug supply planning tasks, activities, and deliverables
Support inspection and audit preparation and execution
Participate in maintenance of SOPs
Participate in internal and cross-functional improvement projects
Responsible for being compliant with Genmab’s quality system

Requirements

Minimum a bachelor’s degree or equivalent in relevant discipline
Relevant work experience within the Pharmaceutical or biotechnology industry
3+ years’ of experience in clinical trial management or clinical drug supply activities is an advantage, including day-to-day forecasting, IRT systems, budgeting, and stakeholder management within CMC and Clinical development
Solid knowledge and understanding of GCP, GMP, and GDP
Ability to work effectively in a fast-paced environment and with tight timelines
Proactive, goal oriented, and able to prioritize tasks effectively
Strong team player with a demonstrated ability to collaborate with a diverse range of internal and external stakeholders
Enjoys contributing to team spirit initiatives and actively embraces the collaborative and social culture within Drug Supply
Strong communication skills in English, both written and verbal

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

clinical trial managementdrug supply activitiesbudget forecastingIRT systemsGCPGMPGDPrisk managementdocumentation managementSOP maintenance

proactivegoal orientedprioritizationteam playercollaborationcommunicationadaptabilitystakeholder managementproblem solvingtime management