Pre-Screen Data Quality Manager
Care Access Research
Data Science, Quality Assurance
United States · Remote
Posted on Wednesday, January 31, 2024
What We Do
Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
The Pre-Screening Data Quality Manager will serve as an integral part of our organization, overseeing the data quality process for the Care Access Pre-screening Program. The individual will ensure that data collection quality checks are in place for each pre-screening program, queries are generated and resolved promptly, and quality trends are escalated to the Care Access central compliance team and staff managers when appropriate. Additionally, the Data Quality Manager may train and maintain a small team responsible for this process.
What You'll Be Working On
· Develop the data quality plan in coordination with the central compliance team, site network leadership, and pre-screening event leadership.
· Work closely with site personnel to ensure the clinical data is accurate and complete.
· Create training materials for the on-site data quality plan for the pre-screening training team.
· Follow up with Site management to resolve queries promptly, ensuring quality data throughout the project.
· Maintain quality dashboard and report findings and trends to sites and leadership.
· Adjust the on-site data quality plan where necessary based on data trends and assist in facilitating training/re-training as needed.
· Operationalize and implement the pre-screening data quality process for the pre-screening program.
· Regularly review and assess the process for potential improvements in efficiency and accuracy.
· Maintain a call schedule for overseeing data quality at all sites active on a certain pre-screening project.
· Ensure all Care Access sites are aligned in their processes, company SOPs, and program-specific protocols regarding data quality checks, escalating where appropriate.
· Ensure all processes are compliant with state-specific guidelines, legal, regulatory, and organizational policies.
Physical and Travel Requirements
· This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
What You Bring
Knowledge, Skills, and Abilities:
· Leadership qualities
· Successfully able to manage multiple sites/projects.
· Project Management Experience
· Strong organizational skills: Able to prioritize, support, and follow through on assignments.
· Thorough knowledge of company SOPs and Care Access Project Specific process flows/ expectations
· Excellent working knowledge of federal regulations, good clinical practices (GCP)
· Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors.
· Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring a positive and supportive attitude to achieving these goals.
· Strong computer skills with demonstrated abilities using clinical trials databases and Microsoft systems.
· Ability to balance tasks with competing priorities.
· Critical thinker and problem solver.
· Maintain a positive attitude under pressure.
· High level of self-motivation and energy.
· Must have a client-service mentality.
Certifications/Licenses, Education, and Experience:
· 4-5 years of Clinical Research experience, CCRC Preferred
· Regulatory submission and Investigator Site File experience
· Strong knowledge of GCP-ICH requirements and data collection in a research setting
· Proficient in research terminology and medical (basic) terminology
· Strength in communication, planning, and time management skills
· Strong People Skills
· Microsoft office and computer skills
Benefits (US Full-Time Employees Only)
● PTO/vacation days, sick days, holidays.
● 100% paid medical, dental, and vision Insurance. 75% for dependents.
● HSA plan
● Short-term disability, long-term disability, and life Insurance.
● Culture of growth and equality
● 401k retirement plan
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.
At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the
physicians and caring for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.