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.


Clinical Data Manager

Department: Development Operations
Location: Incyte Corporate Headquarters

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. 

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary  (Primary function)
The Clinical Data Manager performs activities pertaining to the conduct of Phase I – III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines.  The CDM ensures, from a data management perspective, assigned trials on time, within budget, and with highest achievable quality.

Essential Functions of the Job  (Key responsibilities)

  • Participate as the primary data management representative on Incyte multidisciplinary project teams and ensure effective communication exchange.
  • Responsible for communicating key clinical data management metrics (e.g., data entry status, query resolution and aging, etc.) and determining appropriate actions in conjunction with study team.
  • Responsible for the review, development and/or writing of clinical trial documents and manuals, including but not limited to Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines.
  • Participate in User Acceptance Testing (UAT), as needed.
  • Participate in Quality Control (QC), as needed.
  • Responsible for working with the assigned Clinical Database Programmer(s) to ensure the development of the Data Flow Chart(s), Data Transfer Specifications and Import Guidelines.
  • Assist with site and/or third party vendor training on CDM-related topics.
  • Responsible for providing data review training and guidance to Sr. Clinical Data Coordinators that are supporting their trial(s).
  • Perform data review and discrepancy resolution, as needed.
  • Responsible for archiving trial(s) and associated documentation upon trial(s) completion.
  • Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

 

Qualifications (Minimal acceptable level of education, work experience, and competency)

  • Minimum of 5 years of data management experience is required.
  • Bachelor’s degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT) is preferred, but individuals with commensurate experience will be considered.
  • Experience with Electronic Data Capture (EDC) system(s) is required.
  • Experience with Oracle Inc.’s Inform™ EDC system is preferred.
  • Oncology and/or inflammatory therapeutic area experience is preferred.
  • Project management experience (within Data Management) is preferred.
  • Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is preferred.


Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.   Management reserves the right to change or modify such duties as required.

 

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application out if you do not meet certain objective criteria required by the job.   You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. 

You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

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