Ref #: 37126

Employment type: Permanent - Full-Time

Location: Warsaw, Poland

Posted: 23-Apr-2022


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.

Services Overview:
Responsibilities include serving as liaison between the business community and TMF CoE/EBIS partners to provide guidance on Study Start-Up process, business use of V-TMF Study Start Up (SSU) and CLIX Document Exchange (DocX) capabilities and leadership in development of business solutions to meet user needs. Supports process design and documentation as needed. Reviews metrics and trends and communicates these findings to Management to proactively identify gaps in process and efficiencies. Collaborates with other members of the team and the business in the translation of business needs into specifications for the solution. Serves as point of contact for initial process discussions when new departments or organizations are being brought into the TMF system using SSU an DocX.

• Understands Clinical Trial processes in order to identify opportunities to automate or streamline EBIS business processes and system functionality.
• Resolves most problems directly within the area of responsibility, or by escalating the problem to the correct resource.
• Follows established procedures to test new software or enhancements to existing software.
• Participates in and Supports Audits/Inspections as needed.
• Responsible for supporting SSU and DocX business user questions within the applicable solution and in collaboration with the technical support team.
• Supports study team in resolution of site staff end user questions and adoption of system.
• Responds to user problems, explains new technologies and presents deliverables.
• Forms productive relationships with internal business partners by listening, clarifying and responding effectively.
• Coordinates and leads discussions as point of contact for the on-boarding of new departments or organizations
• Coordinates alignment in use of SSU and DocX system functionality between sectors
• Works independently or as a part of a team under general supervision.
• Must understand and be compliant with TMF COE SOPs, WIs and guide lines.

Education and Experience Requirements/Qualifications:
• A BA/BS degree is required. A degree in health, science or information technology is preferred.
•Good understanding of the drug development process including ICH/GCP and local
regulatory requirements. Experience in database administration and/or the familiarity of electronic trial master files is preferred.
• Minimum 3 years on the similar position is required
• e-TMF experience is required; Veeva Vault experience is preferred. Ability to provide general business-oriented assistance. Superior communication, problem solving, and prioritization skills are also required. The individual must be self-motivated with a track record of demonstrated aptitude in working in a team-driven environment.

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 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 through the form below.