Clinical Research Data Manager - 230529

Job Title:

Clinical Research Data Manager

Location: West Hollywood, California 90069

Pay: $80,000 - $100,000

Job Purpose:

The Clinical Research Data Manager supports all clinical research activities under the guidance of the Principal Investigator.

Description:

The Clinical Research Data Manager is responsible for managing data for all clinical research studies. This includes maintaining regulatory files to meet research requirements, working with the study monitor to ensure accurate data collection, and assisting the investigator and study coordinator in clinical settings.

Responsibilities:

• Data Management: Oversee data collection, transcription of patient data, and study-related information into research records (CRFs). Maintain source files to comply with research requirements.
• Collaboration with Study Coordinator: Maintain screening and enrollment logs, track patient progress, and monitor protocol compliance.
• Regulatory Document Preparation: Prepare and submit regulatory documents such as CVs, Laboratory Certificates, FDA Forms, 1572s, Financial Disclosure Forms, Training Certificates, Delegation of Authority Forms, and IRB submissions and approvals.
• Study Budget Management: Collaborate with study sponsors to negotiate and finalize study budgets, track expenditures, ensure adherence to the budget, monitor payments, and generate invoices.
• Oversight of Data Coordinators: Delegate and prioritize workloads of Data Coordinators to meet deadlines.
• Administrative Support: Provide general administrative support to the research team as needed.
• Technical Skills: Operate company computer for email, calendars, and other office software.

Additional Duties:

• Data collection and management for clinical research studies.
• Data analysis, presentation, manuscript creation for publication, and technical reports for external queries and research grants.
• Management of daily scheduling, logging, and transfer of research blood specimens.
• Perform other site managerial duties as needed.

Requirements:

• Bachelor’s degree in a health-related field or equivalent work experience.
• At least 2 years of management experience in a clinical research setting.
• Strong organizational skills to support data management and monitoring for multiple clinical trials and projects.
• Working knowledge of medical terminology specific to oncology.
• Understanding and maintenance of confidential information.
• Advanced knowledge of Electronic Data Capture (EDC) database programs.
• Ability to prioritize workload to meet demands of Principal Investigators, Sponsors, and FDA.
• Knowledge of FDA regulations including GCP, IND Regulations, IRB Regulations, FDA Code of Federal Regulations (Title 21 CFR), Clinical Trial Registration and Reporting, Drug and Device Approval Processes, Adverse Event Reporting, and Labeling and Marketing Regulations.
• Experience in protocol development in collaboration with study sponsors and investigators.
• Strong interpersonal skills to work effectively with patients, families, physicians, administrators, colleagues, sponsors, and others.
• Ability to notify direct supervisor of any conflicts in demand on time or priorities.