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 II oversees all data management activities for assigned projects in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met.

Essential Functions of the Job (Key responsibilities)

• Participate as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange.
• Participate in protocol development and review; participate in review of clinical study reports and statistical analysis plans, as required.
• Review and provide input to CRF design and ‘CRF Completion Instructions’.
• Develop test scripts and perform user acceptance testing and validation of the database used to collect the clinical data to ensure that they meet requirements for the entry and reporting of clinical data.
• Perform training for appropriate users of the clinical data management system, as required.
• Produce ad-hoc or standard listings of data from the clinical data management system using the reporting tools provided, as required.
• Contribute to the ongoing development, review and revisions of Clinical Data Management Standard Operating Procedures (SOPs).
• For outsourced studies:
  • Collaborate with the Clinical Research Organization (CRO) project team to ensure that study deliverables and timelines are met and to act as the primary point of contact for data management interactions with the CRO.
  • Participate in the development of proposal specifications, review CRO proposals and budgets and assist in the selection of CROs for outsourced work.
  • Monitor the quality of Data Management processes, data and CRO performance.

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

• Bachelor’s degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT).
• Minimum of 5 years of data management experience.
• Project management experience is required.
• Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required.
• Oncology, endocrine and/or inflammatory therapeutic area experience 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.

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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 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.