at Incyte Corporation in Wilmington, Delaware, United States
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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