Senior Study Manager

Senior Study Manager

Summary

The Senior Study Manager's primary responsibility is to coordinate and manage all Symphony- contracted services in assigned global study(s), providing quality service, and exceeding the expectations of our customers. The Senior Study Manager manages the key global 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.

The Senior Study Manager will be assigned the more complex studies on behalf of Sponsors. It is also expected the Senior Study Manager will be capable of managing a larger volume of study visit activity, which may be across a variety of study types.

The Senior Study Manager will also assist the Team Leader in training the entire study management team.

Essential Duties and 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 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

• Participate/Lead study team reviews with country study managers
• 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

Qualifications

* Excellent judgment and decision-making ability

* Outstanding communication skills (written and verbal)

* Well-organized and able to multi-task

* Able to work independently and as an effective member of a team

* Superior problem identification and resolution capability

* Committed and able to produce quality and timely results

* Takes initiative, proactive

* Detail and process-oriented

* Capable of earning the professional respect of all stakeholders related to a study

* Demonstrates the ability to build strong positive relationships with others internally and externally

* Customer-oriented

* Understands and demonstrates compliance with relevant regulations including ICH/GCP, HIPAA, IATA,

* Highly productive

* Demonstrates project management skills

* Comfortable working with team members residing in other countries

* Proficient with clinical trial management systems, Microsoft Excel & Word

Education and Experience

* Bachelor's 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

* Training external and internal team members