Project Manager I

Job Description:

• Accomplish the day-to-day operations of project management and administer activities regarding assigned studies
• Support all study activities from study start-up through closeout and data lock
• Assist with project management of clinical trial data in the EXCELSIOR™ cloud application environment
• Perform data uploads and quality control functions
• Organize, coordinate, develop, proofread, and maintain controlled project and regulatory documents
• Respond to quality review audits and document responses
• Assist with development and implementation of training programs
• Prepare study start-up materials, organize internal start-up meetings, and follow up on action items
• Maintain communication among the Project Management Division, sponsors, site staff, and other designated parties
• Initiate and maintain Master Project Files and study files
• Establish, create, distribute, and maintain study documents, reports, updates, status information, site lists, plans, correspondence, eligibility reports, and notifications
• Attend internal and sponsor project meetings via teleconference or face-to-face
• Independently process clinical data from start-up through database lock
• Understand EXCELSIOR™, clinical trial protocols, and clinical trial conduct
• Provide guidance and training to sponsors, CROs, and clinical sites on EXCELSIOR™ functionality and technical support
• Configure studies within EXCELSIOR™ and assist with study-specific configuration review
• Develop and perform project-specific user acceptance testing
• Train internal teams and provide additional training support as required
• Manage and review site surveys and update EXCELSIOR™ for site registration
• Perform clinical site technician and equipment certification
• Check in and quality-control images
• Issue and review data query responses
• Review, categorize, and respond to customer support and complaint tickets
• Follow up with sites, sponsors, and reading center personnel regarding EXCELSIOR™ access and inactive users
• Comply with company policies and Standard Operating Procedures (SOPs)

Requirements:

• Minimum of a Bachelor’s degree in a health related, biological science, computer science, data entry, customer service or business management is preferred, or an equivalent combination of education, training, and work experience
• A minimum of two (2) years of clinical trial or project management experience in a related field
• Strong interpersonal and organizational skills
• Excellent attention to detail
• Ability to follow direction, assess Company needs and work independently
• Proficiency in Microsoft Office software
• Ability to learn Company specific software
• Professional attitude and image appropriate for the work environment
• Ability to participate and contribute in a team environment
• Clear, concise, and effective oral and written communication
• Must meet the stated physical requirements, including frequent lifting/moving up to 10 pounds and occasional lifting/moving up to 25 pounds
• Licenses or Certifications Required: None