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.
The Project and Operations Manager, Translational Sciences (12 Month Work Contract)
Job Summary (Primary function)
The Project and Operations Manager, Translational Sciences supports execution of our clinical biomarker programs by facilitating the transition of translational strategies into biomarker operational plans.
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.
Demonstrate knowledge of ICH and GCP.
Direct experience with data management and working with 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.
Self-motivated, proactive, and able to prioritize and manage multiple projects simultaneously.
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:
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, and your supervisory authority (if applicable).
Please contact email@example.com if you have any questions or concerns or would like to exercise your rights.
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.