At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Overview of the role:
Title: Senior Study Manager, Home Health
Location: Remote USA- (It is preferable that candidates are located in EST, CST, MST).
Job Type: Full-Time Permanent (This role will require occasional after-hour coverage to support in-home visits but it will vary by study and frequency of visits)
Summary:
The Senior Study Manager’s primary responsibility is to coordinate and manage all services in assigned study(s), providing quality service, and exceeding the expectations of our customers. The Senior 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 Senior Study Manager is expected to accurately identify issues and creatively resolve problems while correcting processes as needed.
Duties:
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 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 Symphony 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 Symphony 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
· Provide support and oversight for project financials and forecasting
· Perform other duties as assigned
Role Requirements:
· Bachelors Degree (preferably in the life sciences or healthcare field) or 10 years’ industry experience
· 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 with training external and internal team members
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
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.
