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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates proficiency in project management activities, particularly in clinical trial settings, with a strong focus on document management, quality control, and effective communication. Capable of utilizing EXCELSIOR™ for data management and providing support to clinical sites and stakeholders.
Highest-signal resume keywords
Project ManagementClinical Trial CoordinationEXCELSIOR™ ProficiencyMicrosoft Office ProficiencyAttention to Detail
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 CoordinationData Quality ControlDocument ManagementEXCELSIOR™ ConfigurationData UploadsEligibility ReportingRegulatory Document CreationQuality Review AuditsCustomer Support
Soft Skills
Interpersonal SkillsOrganizational SkillsEffective CommunicationProblem-SolvingTeam Collaboration
Tools & Technologies
EXCELSIOR™Microsoft Office
Industry Keywords
GCPClinical TrialsHealth CareService-Related EnvironmentStandard Operating Procedures
Tech Stack
Tools & technologiesCloudGoogle Cloud Platform
About the role
Key responsibilities & impact- Assist the Project Management Division with coordination and conduct of project management activities
- Create and distribute study-related documents and coordinate study activities
- Assist with project management of clinical trial data in the EXCELSIOR™ cloud application environment
- Perform data uploads and quality control functions
- Maintain controlled documents, including Master Project Files
- Provide support to clinical sites, reading centers, and clients using EXCELSIOR™ according to company and study-specific procedures and GCP
- Organize and coordinate controlled documents and assist with study management
- Develop, proofread, create, duplicate, and disseminate project and regulatory documents
- Assist with quality review audit responses and training program development/implementation
- Monitor work quality and completeness
- Assist with study activities from start-up through closeout
- Organize and prioritize assignments, anticipate problem areas, and solve problems creatively
- Assist with study-specific processes, procedures, reports, and updates
- Generate and email eligibility reports and notifications
- Attend internal and sponsor project meetings via teleconference or face-to-face
- Maintain study systems, procedures, site information lists, plans, study documents, and correspondence
- Configure studies in EXCELSIOR™ and assist with configuration reviews
- Manage and review site surveys and update EXCELSIOR™ for site registration
- Provide guidance, training, and technical support to sponsors, CROs, clinical sites, and graders
- Perform clinical site technician and equipment certification
- Check in images and perform image quality control
- Issue and review data query responses for completeness and accuracy
- Review, categorize, and respond to customer support and complaint tickets
- Follow up on EXCELSIOR™ access and review inactive user reports
- Comply with company policies and Standard Operating Procedures
Requirements
What you’ll need- BA or BS degree from a four-year college or university
- Some related experience and/or training in administrative or customer service, preferably in a health care or service-related environment, or equivalent combination of education and experience
- Preferred experience in clinical trial or project management 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 to a team environment
- Clear, concise, and effective oral and written communication
- Ability to use hands; touch, finger and grasp, handle or feel, with repetitive motions
- Ability to talk or hear
- Ability to stand, walk and sit
- Ability to reach with hands and arms, stoop, crouch, kneel and climb
- Ability to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
- Close vision, color vision, peripheral vision, depth perception, and ability to adjust focus
Benefits
Comp & perks- Flexible schedules
- Remote opportunities
- 401(k) Retirement Plan
- Dental insurance
- Health insurance
- Paid Life insurance & AD&D
- Paid Long-Term Disability
- Paid Time Off (Vacation and Sick)
- Paid 8 Holidays
- Vision insurance