Associate Study Manager

Associate Study Manager

Summary

The Associate Study Manager is a position for clinical resources to build the expertise and knowledge for managing in-home services for Symphony's customers. This position will begin with US-only studies, and continue to take on more responsibilities and challenging studies as well as assist with or lead international studies, as their performance warrants.

The Associate Study Manager will be mentored by the Clinical Operations team, along with the head of Clinical Operations to gain more knowledge and insight in managing global studies

The primary responsibility of the Associate Study Manager is to learn through hands-on experience, the various aspects of managing in-home services, project management skills, and designing and implementing the most effective in-home service model for their assigned studies with the help from Symphony's subject matter experts. The goal is to move the Associate Study Manager into the Study Manager position.

The Associate Study Manager is responsible for coordinating and managing Symphony-contracted services in assigned studies, accurately identifying and managing issues and continuous improvement, ensuring study documentation is accurate and timely, keeping all stakeholders informed in a timely and professional manner about the progress and key events with the study.

Essential Duties and Responsibilities

• Support and/or be the lead study manager with the administration, coordination and management of study activities, including but not limited to:
  • Maintaining study project plans and adhering to study commitments and timelines
  • Development of study specific logistics and documentation for review and approval by Sponsor
  • Relationship management with the sponsor, CRO, investigative site staff, laboratory, pharmacy and other internal and external personnel
  • Participate in Sponsor IM's and SIV's
  • Project calls, webinars, teleconferences and meetings
  • Scheduling training, conducting training with subcontracted clinicians;
  • Entry into CRM and review of study CRM reports
  • Pre-visit and post-visit follow-up with clinicians
  • Review of study documentation for accuracy, completeness and turnaround times; solicit information to support inquiries;
  • Filing of study communications Handle, or seek advice in order to handle, sensitive issues effectively
  • Other duties as assigned
• Transition into the lead study manager role and assume all responsibilities, if not already leading studies
• Ensure high satisfaction of all stakeholders
• Ensure visits are not missed, documentation is timely, complete and accurate and lab samples are evaluable
• Comply with ICH/GCP, IATA, HIPAA, Data Privacy and other appropriate regulations

Qualifications

• Detail-oriented; and process-oriented
• Highly productive; Takes initiative
• Well-organized and able to multi-task
• Able to work independently or as an effective member of a team
• Able to identify problems and propose a resolution
• Committed to ensuring quality results: Able to produce quality and timely results
• Customer-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
• Demonstrates sound judgment and decision-making ability
• Demonstrates strong communication skills (written and verbal)
• Understands and demonstrates compliance with ICH/GCP, HIPAA, IATA, Data Privacy, Symphony SOP's and other regulations as appropriate
• Applies project management principles to daily activities

Education and Experience

• Minimum Associates Degree, Bachelor's degree preferred
• Minimum of 3-5 years in clinical/medical experience
• 1 Year Symphony experience in Study Support or project management
• Homecare experience desirable
• Comfortable and conversant with clinical trials terminology and practices