Study Manager - Home Health

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.The Role:

This position is based in Gdansk

The Study Manager’s primary responsibility is to coordinate and manage all Symphony-contracted services in assigned study(s), providing quality service, and exceeding the expectations of our customers. The Study Manager manages the key relationships and communication among all internal and external stakeholders involved in a study, keeping all stakeholders informed in a timely and professional manner about the progress and key events with the study. The Study Manager is expected to accurately identify issues and creatively resolve problems while correcting processes as needed.

Responsibilities:

• Coordinate, administer and document all study management activities to include:• Maintain and adhere to study project plans and timelines• Train subcontracted resources, country study managers, nurses or other clinicians• Provide support and guidance for subcontracted resources, including routineteleconferences to review progress to timelines, issue management, and information sharing• Contact country study managers and/or clinicians to ensure visits are scheduled and have occurred per the required timelines• Review study documentation to ensure completeness, accuracy and timeliness• Seek or correct documentation, as needed• Ensure CRM is updated, reports are reviewed and provided to the appropriatestakeholders timely and according to expected timelines• Solicit information to support inquiries from all stakeholders• Support all internal and external team members in their efforts to support the study• Assist in training new team members• Ensure Accellacare is providing quality service• Act as the liaison between the sponsor, CRO, investigative site staff, laboratory, pharmacy andother internal and external personnel as the study requires• Represent Accellacare effectively and professionally in project calls, webinars, teleconferencesand meetings• Recognize sensitive issues and manage them effectively; escalate up when need assistance• Comply with ICH/GCP, IATA, HIPAA and other appropriate regulations, policies and procedures• Ensure that contracted study visits are completed on schedule, documentation is timely,complete and accurate and lab samples are evaluable

• Oversee the budget, request/approve any changes in the budget

• Responsible for monthly billing per each assigned project• Perform other duties as assigned

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.