Job ID: 2022-87813 Type: US-Northeast # of Openings: 1 Category: Data Management
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Responsible for providing end-to-end IVRS support to clinical project teams including but not limited to gathering study specific IVRS user requirements, creating and enforcing IVRS standards, managing vendor performance, monitoring system change requests, and supporting training & education for stakeholders.
Execute IVRS development process from kickoff to system go live, ongoing system change control, and system closeout.
Work with the internal stakeholders and IVR vendors to develop study specific IVR requirements, creates and enforces the use of IVRS standards. Responsibilities may include collaboration with vendors and internal stakeholders to define requirements and develop implementation plans. Ensures adherence to IVRS standards, reviews study team business case proposals, and provides final go / no-go decision regarding requests to utilize custom functionality.
Manage vendor performance and relationship(s) at the study level. Responsibilities may include performing root cause analysis and identifying corrective/preventative actions, and serving as a point of escalation for vendor issues.
Ensure vendor system development processes align with Merck Quality and System Life Cycle expectations.
Monitor system change requests. Ensure adherence to IVRS standards, works with the clinical project team to identify system changes and ensure completion of the changes through its life-cycle. Monitors and analyzes system change requests, and identifies corrective actions for utilization of standards.
May provide support in the following areas:
data transfer issue resolution between IVRS vendors and shipping depots in support of shipping processes, DOF/ERP specifications, and issue resolution.
lock & transfer of allocation schedules to IVRS vendors, the requirement document approval process, or the provision of site & Merck user information to IVRS vendors.
development / maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documents.
process improvement activities.
training and education for stakeholders including develop, or assist in development of, reference and/or training material; may provide cross-functional internal and external communication as needed.
Education and Work Experience:
2-4 years of experience in clinical supplies, clinical research, or database design & development
B.A./B.S. in biology, life sciences, computer science, or related field
Knowledge, Skills, and Abilities:
Demonstrated knowledge of IVRS development processes.
High level understanding of clinical supply chain within the pharmaceutical industry.
Knowledge of databases, structure, & corresponding tools used to manage, extract, & report data.
Working knowledge of clinical development and statistical concepts.
Effective written and verbal communication skills.
Ability to organize and manage multiple tasks at one time and meet deadlines in a complex environment working both internal to Merck and external to Merck.
Average proficiency with Microsoft applications (Word, Excel, PowerPoint, Project).
Working knowledge of regulatory requirements (e.g., GMP), quality procedures and SOP execution.
Benefits of Working in ICON:
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.
At 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.
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, color, 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.