42 applicants
Care Access ยท 2 days ago
Pre-Screening Data Quality Manager
United States
Full-time
Hybrid
Mid Level
4+ years exp
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Responsibilities
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.
Qualification
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Required
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
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
PTO/vacation days
Sick days
Holidays
100% paid medical, dental, and vision Insurance
75% for dependents
HSA plan
Short-term disability
Long-term disability
Life Insurance
Culture of growth and equality
401k retirement plan
Company
Care Access
Care Access is a global research site that accelerates the availability of new treatments by enabling more communities to gain access clinical research.
501-1,000 employees
Funding
Current Stage
Late StageLeadership Team
A
Ahmad Namvargolian
CEO & Co-Founder
Recent News
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