Project Design Manager I

About the role

The Project Design Manager I position at Clinical ink is based remotely across the United States. This role involves working with complex protocols to translate them into DDC and eCOA system requirements, collaborating with internal teams, and conducting customer meetings to ensure alignment on system functionality.

Responsibilities

• Review client protocols and other project documentation to assess the scope of the build and communicate it to the appropriate internal teams
• Complete/oversee eCOA builds with support from Manager as needed
• Work with Study Operations Leads to identify needs and resources for study build
• Define system requirements based on protocol, data collection needs, data export requirements, regulatory guidelines, and application functionality
• Update study requirements throughout the design process as needed
• Perform internal UATs
• Lead internal meetings regarding the study build project
• Lead customer-facing meetings regarding the design of assigned builds
• Oversee client UAT by creating UAT database and entry forms, managing client UAT kick off and review meetings, addressing/communicating scope issues, and updating study build based on UAT feedback
• Generate and update study-related reports
• Create and maintain standard libraries in eSource design tool
• Work with Project Management, Project Data Management, and Clinical Programming to draft, review, approve, and update applicable project build and change control timelines
• Communicate with Project Data Management and Clinical Programming to ensure mapping and export requirements are being met
• Oversee peer training
• Assist with scoping Change Control requests
• Other duties as assigned

Qualifications

• Bachelor’s degree in clinical trial design or equivalent work experience
• Ability to identify needs/issues, track progress, and follow through on actions to meet customer satisfaction
• Excellent written, verbal, and interpersonal communication skills
• Strong organizational skills, attention to detail, and ability to multi-task are required
• Experience with MS Office including Word and Excel
• Must be able to work independently following a brief period of specific technical training; self-starter
• Exhibits proficient knowledge of clinical research, regulations, protocol design, site workflow, etc.
• Ability to learn complex applications and processes in a short period of time

Additional Information

At Clinical ink, we are committed to an inclusive environment and do not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.