Project Design Manager I

Company Information

Clinical ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data precision and usher in a new generation of clinical trials. With offices in Philadelphia, PA, Winston Salem, NC, and Iowa City, IA, Clinical ink is rewriting the clinical development experience.

Job Description

Clinical ink is seeking a Project Design Manager I to join our Study Build team based remotely across the United States! To be successful in this role, you will have experience in clinical research and have the ability to understand and translate complex protocols into DDC and eCOA system requirements. You will also work cross-functionally with internal teams and conduct customer meetings to ensure alignment on system functionality. Your responsibilities as a Project Design Manager I will include:

• Review client protocols and other project documentation to assess the scope of the build and communicate it to the appropriate internal teams
• With support from Manager as needed, complete/oversee eCOA builds
• Work with Study Operations Leads to identify needs and resources for study build
• Define system requirements (i.e. application configuration, form content, metadata, and functionality) based on protocol, data collection needs, data export requirements, regulatory guidelines for collecting source data/applicable standards, 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 in drafting, reviewing, approving, and updating applicable project build and change control timelines
• Communicate with Project Data Management and Clinical Programming to ensure mapping and export requirements are being met
• Assist in maintaining reference documentation
• Support 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 processed in short period of time

Additional Information

Clinical ink is an equal opportunity employer and does 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.

www.clinicalink.com