The Drive to Discover. The Experience to Deliver.

Careers At Incyte Corporation

Looking for a challenge and a chance to grow your career?

Then Incyte is the pharmaceutical company for you. While our pipeline demonstrates the ability to compete with much larger pharmaceutical companies in selecting compelling targets and creating high-quality drug candidates, our smaller size enables employees to see the direct impact of their contributions on the direction of the company. Due to our smart, agile culture and cutting-edge science, we delivered a novel, first-to-market product in an unmet medical need in 2011 - the first in the company's history.

Opportunities for taking on new and/or additional responsibilities, in addition to advancement, are a key element in our culture. Add to that a science-based, fast-paced work environment and you’ve got an exciting company in which to work.

In addition to opportunities for growth, we offer an outstanding benefits andcompensation package to help meet personal needs as well.

Take a look at our current openings to find the match that’s right for you!

Incyte Corporation values the talents of our diverse workforce and is proud to be an Equal Opportunity Employer.


Study Start Up Specialist

Department: Development Operations
Location: Amsterdam, Netherlands

Summary

Under the guidance of the EU Study Start-Up Manager of Clinical Trial Logistics, this position will be responsible for conducting end-to-end site start-up from feasibility to site activation serving as the primary point of contact for the site and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and site start-up activities.

 

Duties and Responsibilities

  • Serve as primary point of contact to study team on end-to-end start up activity
  • Participate in or lead  Study-Start-up team meetings as appropriate
  • Utilize Study Start Up tools to track activities and develop reports
  • Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires
  • Conduct site contract/budget negotiations (Confidentiality Agreement and Clinical Trial Agreements)
  • Collect essential documents from sites, tracking & review led by Document Management Team
  • Support the collection of country and site level intelligence
  • Complete, manage and/or support Ethics Committee and Regulatory Authority submissions
  • Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate.

Requirements

  • At least 5 years experience in site start-up and contract management in pharmaceutical company or in clinical research organization.
  • BA/BS degree in Science or related field.
  • Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures.
  • Strong presentation, documentation, and interpersonal skills.
  • Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet.
  • Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
  • Excellent oral and written communication skills.
  • Proficient in Dutch, French and English
  • Excellent planning and organizational skills with effective time management.
  • Excellent interpersonal skills.
  • Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
  • Thorough understanding of clinical research principles and process.
  • Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and country/local regulatory requirements (preferably in Belgium, the Netherlands and if possible also in France).
  • Goal oriented, self-starter with proven ability to work independently;
  • Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines;
  • Comfort with ambiguity; ability to act without having the total picture.
  • Ability to proactively identify and solve problems.

 

 

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