Genmab is looking for a motivated Clinical Start-Up Lead to join the Global Clinical Operations team. The position can be based at our offices in Copenhagen, Denmark or Princeton, NJ USA.
Global Clinical Operations is part of the Clinical Development department which is responsible for managing clinical cancer trials from early First-in-Human (FIH) studies to late-stage trials.
As Start-Up Lead, you will be responsible for supporting the CTM with start-up activities for Phase I-III clinical trials and ensure knowledge is transferred between trials both within but also across projects to secure a successful and timely start-up.
As Clinical Start-up Lead, you will be reporting to the Associate Director, Team Lead, Start-Up and Trial Management, and join a trial management team of Clinical Trial Managers, Sponsor Oversight Leads, Start-Up Leads, and Clinical Trial Assistants in Copenhagen and Princeton.
This position can be based in Princeton, NJ USA; Copenhagen, Denmark; or Utrecht, The Netherlands.
- Site CDAs
- Site contracts and budgets
- Involved in PI/ICF master development
- Review of country/site specific PI/ICFs and communication with the CROs Support activities in relation to IRB/EC/CEC submissions and questions
- RGL review
- Ensure collection of 1572 forms and reconciliation
- A minimum of 3-5 years of relevant experience in the biotechnology/pharmaceutical, CRO or healthcare industry
- Bachelor’s Degree within life science or equivalent combination of education, training, and relevant experience
- Experience in Clinical Operations and a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines would be beneficial
- Experience in project management and either site contract or budget drafting, negotiation, and execution across Phase I-III clinical trials
- Excellent communication (oral and written) and negotiation skills, including conflict resolution, decision making and presentation skills
- Strong organizational skills, including the ability to prioritize and handle a high volume of tasks within a given timeframe
- Proficient with both written and spoken English
Moreover, you meet the following personal requirements:
- You can work independently as well as in teams
- You are capable of prioritizing work in a fast paced and ever-changing environment
- You have a quality focus and an eye for detail
- You are result and goal-oriented and committed to contributing to the overall success of Genmab