eCOA Application Specialist

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.

This position can be based anywhere globally

Home or office based

Mapi Research Trust (MRT) is a non-profit organization dedicated to improving patients' quality of life by facilitating access to Patient-Centered Outcome (PCO) information. We promote scientific approaches in the PCO field and encourages exchanges between academics, pharmaceutical companies, and international organizations around the world in the service of incorporating the patient's voice into every step of the development process of new treatments.

As more and more clients are digitalizing the COAs, we are developing our team's experience with electronic COA processes.

Within the Trust, the eCOA Project Manager is responsible for handling project's clients about eCOAs (Clinical Outcomes Assessment). Most of the work is about giving support and coordination on electronic implementation, about how to use COAs in a clinical trial or any other study including conditions of use, licensing process, availability of translations and delivering licenses for the use of COAs.

The Project Manager supports all project's steps and coordinate different stakeholders through the independent management of assigned projects and tasks. The Project Manager acts as the Subject Matter Expert and consults on each project to ensure best practices are implemented for each technology implemented in a study, on time delivery, and remediation of issues for multiple projects simultaneously.

The Project Manager works closely with other members of the project team, client, clinical/scientific teams, copyrights holders and internal and external clients and vendors for successful project execution. The Project Manager has a firm grasp on the process and deliverables of their functional team and actively contributes to process improvements.

Key Responsibilities:

• Subject Matter Expertise in the areas of eCOA and other technologies
• Strong working knowledge of Microsoft Office tools
• Solid technical background, with understanding or hands-on experience in software development and clinical technologies (EDC, eCOA, IWRS etc.)
• Experience with SQL (querying databases) / SaaS delivery / with agile development processes (scrum)
• Provide technical direction for the development, design, and systems integration for customer engagements
• Excellent expertise of Project Management principles (certification is a plus PMP / PRINCE II, CAPM, PgMP, etc.) to define and monitor project scope, budget, timelines, resources, quality (all effective internal and client policies and standards) and deliverables for the full project life cycle
• Manage day to day planning, execution, financial and timeline management of multifunctional projects with varying complexity while adhering to SOPs and performance metric standards
• Identifying and resolving issues that may negatively affect operationalization of eCOA tools and the project. Escalating issues to leadership as needed.
• Adaptation to change and competing priorities
• Regular internal reporting (dashboards, meetings, risk management, action plan, presentations, …)
• Establish strong customer relationships and seek opportunities to increase customer satisfaction and deepen relationships; Communicate effectively to qualify their needs and propose solutions, inform them of the project status
• Ensuring clients' satisfaction by analyzing their needs, working with them to understand study specific eCOA designs and requirements, offering appropriate solutions and quotes. Advising sponsors on best solutions to adopt, providing technical expertise.
• Coordinating with internal teams involved in the project and with external parties (such as authors, copyright holders and eCOA vendors) to ensure eCOA study requirements and specifications are clearly understood and documented
• Responsible for managing the development, review and approval of project related study documentation during throughout the full life cycle of the project implementation
• Development of guidelines of eCOA's operationalization including creation of Original Electronic Versions (OeV) and coordinating reviews with copyright holders
• Participate or lead internal and external workshops to discuss screenshots review, expert review, BYOD, eLibraries, certification processes etc,
• Explain and promote the company products and services in an effort to maintain and expand the current and prospective client base
• Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and easily followed.

Education, skills and experience required

• Bachelor's degree in related field or equivalent experience
• Minimum of 3 years' experience in IRT/eCOA or related field
• You will have significant experience in eCOA, research technology, Outcomes Research, or eClinical/Clinical field or related services/industry.
• Comfortable managing a variety of tasks at one time
• Strong leadership, influencing, and motivational skills
• Excellent communication skills
• Fluency in English both verbal and written
• Analytic, problem-solving skills
• Focus on continuous improvement

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 through the form below.

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