Lead Database Architect - Remote

Overview

The Lead Database Architect (LDBA) is to be the subject matter expert pertaining to eCRF design, database configuration and edit check programming. The LDBA will be responsible for all clinical database configuration in compliance with Standard Operating Procedures (SOPs) and current industry/regulatory guidelines.

In Short

• Serve as the technical leader on eCRF design, database creation/configuration and study start-up that will deliver accurate, timely, consistent, and quality clinical trial data.
• Independently perform all activities related to eCRF design and database configuration per regulations and applicable standard operating procedures (SOPs).
• Mentor junior members of the Clinical Data Services group to help ensure eCRF design and database configuration are being successfully executed, per regulations, the contract, and industry expectations.
• Primary contact person for eCRF design and database configuration activities, and is the person ultimately responsible for eCRF design and database configuration deliverables for assigned projects.
• Primary contact person for communication and discussion of topics related to eCRF design and database configuration timelines and deliverables, and first line contact for technical or procedural issues.
• Develop and maintain database configuration specifications, edit check specifications.
• Organize and oversee clinical study database User Acceptance Testing (UAT), and ensure proper documentation thereof.
• Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
• Cooperate and assist the Quality Systems department with quality control audits on assigned databases.
• Other duties & responsibilities as required.

Requirements

• A minimum of 5 years of clinical data management related experience in either a CRO, pharmaceutical, biotech, or device company.
• In-depth understanding of database structures and database programming.
• In depth knowledge of CDISC SDTM/CDASH standards.
• In-depth knowledge of clinical trial processes and experience in ICH, GCP, and GCDMP (SCDM).
• Direct experience with FDA regulations for healthcare such as 21 CFR Part 11A.
• The proven ability to provide leadership and think strategically to achieve business goals.
• Strong analytical, problem solving, and technical skills in database programming.
• Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
• Knowledge of at least one computer programming language is an asset.
• Must have strong communication (both verbal and written), interpersonal, and client services skills.
• Must be highly organized and self-motivated.

Benefits

• Medrio covers the cost of employee premiums for medical, dental, vision, life and LTD insurance.
• Gym membership.
• Promotes an atmosphere of work/life balance, including flexible work schedules and unlimited PTO.