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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in project management and clinical trial operations, with proficiency in EXCELSIOR™ and Microsoft Office. Capable of maintaining regulatory compliance and effective communication among stakeholders throughout the study lifecycle.
Highest-signal resume keywords
Project ManagementClinical Trial OperationsEXCELSIOR™ ProficiencyData Quality ControlInterpersonal Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementClinical Trial ManagementData UploadsQuality ControlDocument ManagementUser Acceptance TestingMicrosoft Office ProficiencyClinical Data ProcessingStudy ConfigurationRegulatory Compliance
Soft Skills
Attention to DetailOrganizational SkillsEffective CommunicationTeam CollaborationProfessional Attitude
Tools & Technologies
EXCELSIOR™Microsoft Office
Industry Keywords
Clinical TrialsProject ManagementHealth SciencesBiological ScienceData Entry
Tech Stack
Tools & technologiesCloud
About the role
Key responsibilities & impact- 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
What you’ll need- 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