What are the responsibilities and job description for the Manager, Clinical Research Data, Gerontology/ADRC position at Wake Forest Baptist Health?
JOB SUMMARY
The Clinical Research Data Manager is responsible for the oversight, administration, and coordination of policies and procedures related to data management within the Alzheimer's Disease Research Center. This role ensures compliance with regulatory standards and contributes to the efficiency and integrity of research data operations.
EDUCATION & EXPERIENCE
- Bachelor's degree in Clinical Research, Biological Sciences, or a related field.
- Minimum of three (3) years of experience in clinical research data management.
- Experience in Academic Clinical Research is preferred.
- Prior data management experience in a hospital, medical school, or clinical research unit is highly desirable.
- Proficiency with R and/or SAS is required.
- Experience pulling data from SQL servers is preferred.
LICENSURE, CERTIFICATION & REGISTRATION
- CITI Certification is preferred.
ESSENTIAL FUNCTIONS
- Provide administrative leadership in interpreting and implementing clinical research data management policies, procedures, and programs.
- Collaborate with research and department leadership to manage data aspects of research programs, including database builds, validation, and case report form (CRF) development.
- Evaluate resource utilization, make recommendations for improvements, and develop systems for continuous monitoring to optimize operational efficiency.
Staff Management & Development:
- Provide oversight for data management staff, including hiring, performance evaluations, promotions, and scheduling.
- Assign tasks and allocate resources to meet department goals effectively.
- Formulate and implement short- and long-term strategies to enhance data management processes and operational efficiencies.
- Ensure all projects comply with operating procedures, Good Clinical Practices (GCP), ICH guidelines, Good Clinical Data Management Practices (GCDMP), FDA regulations, and audit requirements.
- Implement standardized data management procedures to ensure timely and high-quality data submissions aligned with study requirements.
SOP Development & Review:
- Assist in the creation and maintenance of Standard Operating Procedures (SOPs) and work instructions related to data management activities.
- Provide feedback on essential study documents, including protocols, Statistical Analysis Plans (SAPs), and Data Management Plans (DMPs).
- Serve as a liaison between faculty, administration, and external organizations to facilitate operations, contract negotiations, and problem resolution.
- Represent leadership in meetings, conferences, and other administrative engagements.
Reporting & Analysis:
- Prepare operational and financial reports, identifying progress, trends, and areas for improvement.
- Utilize R and SAS for data analysis and reporting.
- Oversee the onboarding and continued training of staff members.
- Conduct training sessions and lectures on data management processes and standards to enhance team knowledge and compliance.
Additional Responsibilities:
- Perform other duties as assigned to support the research unit’s objectives and mission.
SKILLS & QUALIFICATIONS
- Comprehensive knowledge of healthcare administration and federal regulations related to human subject research.
- Proficiency in clinical trial management systems and research data management software.
- Strong leadership and organizational skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities effectively in a dynamic research environment.
