Project Manager I
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Job Description
Remote Project Manager supporting clinical trial studies from start-up through closeout. Configuring EXCELSIOR™ software, processing clinical data, and training sponsors and clinical sites.
Responsibilities:
- 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
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