Overview:
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Responsibilities:
What you will be doing:
* Authoring the protocol and coordinating the overall development of the protocol with study team members, ensuring timely approval and issuance of the document.
* Providing QC review of protocols as needed.
* Reviewing dataset requirements (i.e. trial specific data transfer agreement) for clinical studies with non-compartmental analysis (NCA).
* Writing the Clinical Pharmacology Analysis Plan (CPAP) based on the protocol.
* Generating a logbook with data handling rules prior to the final NCA.
* Performing premliminary, interim, and final PK, PD and/or PK/PD analysis for trials in all phases of drug development.
* Creating of tables, listings and figures, based on the CPAP.
* Drafting the clinical pharmacology sections of the Clinical Study Report.
* QC of analysis, all delivered outputs, and of documents reporting the analysis.
*
Qualifications:
You are:
* Minimum degree: BA/BS in a health, science, or computer science related field.
* 3 years' industry experience.
* Working knowledge of Phoenix WinNonlin is essential.
* Working knowledge of Microsoft suite of software.
* Knowledge of noncomparmental PK analysis and statistical principles.
* Demonstrated written and verbal communication.
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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