Lead Clinical Data Scientist (Lead Clinical Data Manager)

Medrio’s SaaS offering is a key component in the pipeline of getting lifesaving drugs to people who need them. We automate the clinical trial process and offer significant advantages over the competition, including 75% lower cost and quick, easy setup. Founded in 2005, Medrio is privately owned and currently experiencing geometric growth in terms of customers, revenue, and employees.

We are currently look for an experienced Lead Clinical Data Scientist to join our team! 

Position Summary:

The Lead Clinical Data Scientist (LCDS) is to be the subject matter expert pertaining to eCRF design, data management guidelines, and database creation. The LCDS will be responsible for all clinical data management activities in compliance with Standard Operating Procedures (SOPs) and current industry/regulatory guidelines.

Duties and Responsibilities:

• Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities and develop Data Management Plans that will deliver accurate, timely, consistent, and quality clinical trial data.
• Independently perform all activities related to data management per regulations and applicable standard operating procedures (SOPs).
• Mentor junior members of the Data Sciences group to help ensure projects are being successfully executed, per regulations, the contract, and industry expectations.
• Primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.
• Primary contact person for communication and discussion of topics related to data management timelines and deliverables, request for out of scope tasks, and first line contact for technical or procedural issues.
• Responsible for planning and implementing data management timelines and deliverables, for providing database and data management activities status reports, and contributes to the overall project planning, progress tracking and reporting.
• Design and review electronic Case Report Forms (eCRFs). Develop and review eCRF Completion Instructions. Generate and review annotated eCRFs.
• Develop and maintain data validation specifications.
• Fully involved in the 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.
• Regularly communicate and/or respond to data collection sites, third party service providers, and when appropriate sponsors; responding to queries in a timely manner, addressing data collection and/or quality issues effectively ensuring customer expectations are managed appropriately and data-related communications/updates remain current and relevant.
• Perform third party non-eCRF data management activities, including data transfers and Serious Adverse Event (SAE) reconciliation.
• Work collaboratively with the other departments within Medrio to meet project deliverables and timelines for clinical data management.
• Cooperate and assist the Quality Systems department with quality control audits on assigned databases.
• Perform database soft-lock and hard-lock activities.
• Other duties & responsibilities as required.

Qualifications:

• 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.

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.