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Project Specialist

Position Overview:

Management and administration of projects at assigned pharmaceutical clients.  The projects will include clinical data quality services (e.g., EDC, ePRO, IxRS, rater training, endpoint reliability, scale management, cognition, etc.) for said pharmaceutical clients.


Essential Duties and Responsibilities:

Note:  Other duties may be assigned.


Data/Site Management 

  • Manage identification and resolution of clinical trial data inquiries/data changes and communication to internal and external multi-function resources within project teams
  • Manage communications with client (e.g. pharmaceutical sponsor, CRO) and site personnel regarding site/study details
  • Facilitate weekly data review meetings with clinical trial study team leaders
  • Own in-study/maintenance transactional project activities throughout entire project lifecycle, e.g.  project variable fees, inter-department workflow assignment, issue escalation
  • Prepare study materials, including system requirements, data transfer documentation, questionnaires, rater experience surveys, response sheets, and other documents as required
  • Set up master systems, additional study hardware, study site folders, and data folders for clinical trial execution
  • Coordinate and set-up data for system launch as assigned
  • Design and configure unique project systems and manage data for each assigned project, utilizing proprietary IT applications (e.g. RDA, IR2, CDR PRISM, etc.)
  • Produce data reports (e.g., weekly, interim, final, etc.) for submission to pharmaceutical clients
  • Facilitate the closedown and archival of system databases

Training Event Management 

  • Attend international large scale training events (e.g. Investigator’s Meetings, Phase I site staff training) and facilitate training sessions (requires frequent overnight domestic and international travel)
  • Coordinate with clients, vendors, and expert consultants to ensure all logistics, materials, and technologies necessary for successful training events are in place
  • Independently facilitate virtual training sessions (e.g. LiveMeeting) including attendee registration, training execution and issue resolution


  • Oversee project QC activities to ensure compliance within the enterprise Quality Management System
  • Work within project team to develop and implement processes for projects
  • Prepare and maintain in-study project plans, data management plans and study binders which will be executed in collaboration with Project Managers
  • Provide weekly status reports documenting project activities, planned steps and issues
  • Track monthly and quarterly metrics (variable fee budgetary items) and provide to Project Manager for invoicing
  • Training and development of teammates as appropriate
  • Leverage Project Assistant pool resources as required by project management
  • Enhance the Bracket business model by institutionalizing business processes, implementing best practices, templates, and seeking ways to work more efficiently
  • Contribute to the development, enhancement and testing efforts for enterprise IT applications (e.g. EDC, ePRO, IxRS, RDA, IR2, PRISM, CDR System, etc.)


  • Demonstrated proficiency as Senior Project Assistant or equivalent experience for a minimum of six (6) months

Skills & Competencies

  •  (B.S., B.A.)/University Degree or equivalent years of experience
  • Demonstrated analytical and organization abilities coupled with good client relationship skills
  • Exceptional customer service orientation
  • Demonstrated proficiency with computers, especially Microsoft Office (Excel, Access, Word, PowerPoint)
  • Fluency in English (will be required to write, speak and understand English to conduct day-to-day business.)
  • Ability to travel for business trips (overnight business trips expected monthly)
  • Ability to work independently and proactively in a small team environment with a strong attention to detail
  • Comfortable working in a fast-paced, changing environment
  • Flexible working style

Preferred skills:

  • Understanding of pharmaceutical clinical development and/or sales & marketing
  • Background in Pharmaceutical, Medical education and/or CRO
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