Skip to main content

This job has expired

Clinical Start-Up Lead

Employer
Genmab
Location
Princeton, New Jersey (US)
Salary
Highly competitive salary, incentives, and new hire equity grant. No-cost medical benefits.
Closing date
Jun 19, 2022

View more

Job Details

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.


Responsibilities

 

  • 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

     


Requirements

 

  • 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

     

Company

Be part of the extra[not]ordinary™

Are you caring, candid, impact-driven and determined to make a difference? Join our unstoppable team as we improve the lives of patients through innovative and differentiated antibody therapeutics.

About Genmab

Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.

When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.

Company info
Website

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert