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Project and Operations Manager, Translational Scie

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

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 Translational Sciences group at Incyte is seeking an individual to support our biology research and clinical biomarker programs by facilitating the execution of biomarker operational plans. We are looking for a highly motivated individual to work in a collaborative matrix environment focused on delivering impactful translational data in human clinical studies. The position is located in Wilmington DE, with easy access to major east coast cities.

Essential Functions of the Job (Key responsibilities)

 

Support the tactical execution of biomarker sample collection and analysis during clinical protocol development and study start-up, including contribution to protocols, lab manuals, and clinical laboratory worksheets

 

Contribute to activities involving the Data Management team, including eCRF set-up, database build for sites and sample tracking/reconciliation

 

Coordinate informed consent form tracking and clinical program sample storage and tracking using in-house systems and the BioFortis Labmatrix platform

 

Collaborate with Translational Leads to generate workplan timelines

 

Document key team information, decisions, actions, key modifications, resources, timelines and milestones and ensure translational workplans remain on track

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

 

Scientific background (BS, RN, Med Tech) with a minimum of 2 years' experience in clinical drug development or clinical trial execution with exposure to biomarkers, pharmacokinetics or immunogenicity sample activities including sample collection procedures and logistics considerations, and exposure to informed consent language specific to the handling of human tissue specimens

 

Experience working with CROs

 

Demonstrated knowledge of ICH and GCP

 

Direct experience with data management and working with sample management software and/or a LIMS is preferred

 

Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems and controlled sample management systems

 

Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues

 

Excellent teamwork and ability to collaborate with cross functional teams

 

Superior time management, planning, and organizational skills

 

Capable of working on multiple projects simultaneously, organizing workload to meet deadlines and working both independently and collaboratively to achieve goals

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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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 .

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 . 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,... For full info follow application link.

 

We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.        

        

 

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Job Posting: 822607

Posted On: Jul 14, 2021

Updated On: Aug 07, 2021