Study Manager- Home Health
About the role
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ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center 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.
As part of the ICON family now, Accellacare Home Health is the global leader in home health clinical trials making it convenient for patients to participate in clinical research by taking study visits to where they live, work, study or play!
Accellacare is hiring for a Study Manager of Home Health within Accellacare at ICON plc
REMOTE/HOME-BASED - USA
Title: Study Manager, Home Health
Summary: The Study Manager's primary responsibility is to coordinate and manage all 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.
Duties and Responsibilities:
- Coordinate, administer and document all study management activities
- 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 routine
- teleconferences 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 appropriate stakeholders 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 and other internal and external personnel as the study requires
- Represent Accellacare effectively and professionally in project calls, webinars, teleconferences and 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
Qualifications/Requirements:
- Bachelors Degree, preferably in the life sciences or healthcare field
- Minimum 4 years CRA/Study Coordinator or related experience required
- Homecare experience preferred
- Knowledge of clinical trial terminology and practices highly desirable
- Some leadership experience
- Experience training external and internal team members
- ICH/GCP/HIPAA trained & demonstrates compliance
- Outstanding communication skills
- Well-organized and ability to multi-task
- Detail or process-oriented
- Project Management experience
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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