Study Manager

2 tygodni temu

Gdańsk, Pomerania, Polska ICON Clinical Research Pełny etat

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Study Manager, Home Health to join our diverse and dynamic team. As the Study Manager, Home Health, you will oversee the execution of home health clinical trials from initiation through close-out, ensuring that projects are completed on time, within budget, and in accordance with regulatory requirements and company policies.

What You Will Be Doing:
  1. Coordinate, administer and document all study management activities.
  2. Maintain and adhere to study project plans and timelines.
  3. Train subcontracted resources, country study managers, nurses, or other clinicians.
  4. Provide support and guidance for subcontracted resources, including routine eleconferences to review progress to timelines, issue management, and information sharing.
  5. Contact country study managers and/or clinicians to ensure visits are scheduled and have occurred per the required timelines.
  6. Review study documentation to ensure completeness, accuracy, and timeliness.
  7. Ensure CRM is updated, reports are reviewed and provided to the appropriate stakeholders timely and according to expected timelines.
  8. Assist in training new team members.
  9. Act as the liaison between the sponsor, CRO, investigative site staff, laboratory, pharmacy, and other internal and external personnel as the study requires.
  10. Comply with ICH/GCP, IATA, HIPAA, and other appropriate regulations, policies, and procedures.
  11. Ensure that contracted study visits are completed on schedule, documentation is timely, complete, and accurate, and lab samples are evaluable.
Your Profile:
  1. Bachelor's degree in a health-related field or equivalent experience; advanced degree preferred.
  2. Minimum 3 years of experience in clinical research.
  3. Demonstrated leadership skills and experience in managing a team.
  4. Excellent communication and interpersonal skills.
  5. Proficient in English and a good knowledge of Microsoft Office.
  6. Familiarity with ICH/GCP guidelines and other applicable regulatory standards.
What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family:

  1. Various annual leave entitlements.
  2. A range of health insurance offerings to suit you and your family's needs.
  3. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  4. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
  5. Life assurance.
  6. Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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