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Start-Up Lead

Posted: 10/7/2019
Location: Copenhagen, Hovedstaden
Category: Clinical Operations
Req Number: Projects02726

Job Summary

About Us

Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.

The Role

Genmab is looking for a motivated Start-Up Lead to join the Global Clinical Operations team at our Headquarters in Copenhagen. 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 Start-up Lead you will be reporting to the Director, Team Lead Trial Management and join a team of Clinical Trial Managers, Sponsor Oversight Leads and CTAs in Copenhagen and Princeton.

Key Accountabilities

  • Site contracts and budgets
  • Site CDAs
  • Accountable for PI/ICF master development
  • Review and communication with the CROs in relation country/site specific PI/ICFs
  • Support activities in relation to IRB/EC/CEC questions
  • Attend start up calls with CROs
  • RGL review
  • Support CTM with review of trial specific timelines including Site activation
  • Ensure collection of 1572 form and reconciliation

Skills and Experience

  • 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 have the ability to 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.

Other

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.  

If you would like additional information about this position before applying using the link, please contact Jannie Jensen, Onsite Recruiter (jjn@genmab.com)

Genmab has selected Korn Ferry as a global recruitment partner to help us manage your application.

For more information about Genmab please go to www.genmab.com

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