Lead Database Architect

at Medrio

Remote

Job Summary:

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.

Essential Duties and Responsibilities:

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.

Customers or Clients:

Internal, external

Education and Years of Experience:

A minimum of 5 years of clinical data management related experience in either a CRO, pharmaceutical, biotech, or device company.

Working Conditions (include any required travel):

Remote

Other Skills and Abilities:

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.

About Medrio:

Medrio's SaaS offering is a key component in the pipeline of getting lifesaving drugs to the people who need them. We automate the clinic trial process and offer significant advantages over the competition: 75% lower cost, setup in days rather than months, and much better ease of use. Founded in 2005 we are privately owned, profitable, and are currently experiencing geometric growth in terms of customers, revenue, and employees. We believe in wellness! Medrio covers the cost of employee premiums for medical, dental, vision, life and LTD insurance, gym membership, and we promote an atmosphere of work/life balance, including flexible work schedules and unlimited PTO.

The Medrio team is made up of individuals with a wide array of skills and interests, but all have a passion for providing the best possible user experience for our customers. We are looking for smart, collaborative, creative, and conscientious people to help us expand our product capabilities and better serve our customers.

To see detailed information on the data we collect during the application process, and how Medrio complies with data privacy laws, visit our Careers page.

Salary Range: $120,000 - $140,000