ICON Clinical Research

Study Manager

Location
Gdansk
Salary
Competitive
Posted
21 Apr 2021
Closes
29 Apr 2021
Ref
JR070175
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Are you an experienced Study Manager with experience in home health? Are you passionate about playing a key role in driving innovative solutions within home health for clinical research studies?

As part of the ICON family now, Symphony 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!

Study Manager role within Symphony at ICON plc

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.

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
  • Training external and internal team members

Benefits of Working within Symphony at ICON:

ICON provides Study Managers with the innovative resources to be successful in delivering results, inspiring others and becoming a trusted partner. We offer an exceptional benefits package that includes a comprehensive health plan, retirement plans, highly competitive pay, corporate bonus plan, time away from work, and many other incentives amongst an opportunity to grow your career within our organization.

What's Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

To read more about Symphony, an ICONPLC company, click here