Assoc. Spclst, Clinical Data Mgmt; Hybrid

Position Overview

Under the direction of the applicable management, the Clinical Data Manager (CDM) is responsible for executing end‑to‑end data management activities pertaining to clinical trials, including data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with company standard operating procedures (SOPs) and ICH‑GCP guidelines.

• Participate in the development and implementation of data management tools and systems under the direction of the Senior or Lead Clinical Data Manager (SCDM/LCDM).
• Run data integrity check reports in accordance with data review plans and relevant SOPs.
• Raise questions to investigational site staff and internal and external vendors, review responses and corresponding data corrections to confirm identified issue resolution.
• Execute user acceptance testing of data management tools under the guidance of the SCDM/LCDM.
• Escalate overdue items, including outstanding questions and missing visits.
• Assist the Senior/Lead CDM with data management activities to resolve all identified data issues prior to study database lock.
• Complete trial‑level archiving activities, including filing of essential documentation, under the direction of the SCDM/LCDM.
• Maintain compliance with standard key performance indicators at the protocol level.
• Monitor data quality and cycle‑time performance measures, perform root‑cause analysis and implement action plans as needed.
• Proactively communicate with the Senior/Lead CDM to share project status, risk assessment and outstanding item resolution status.

• High School Diploma (or equivalent).
• Preferred B.A. or B.S. degree in Medicine, Pharmacy, Nursing, Biological Sciences, or a health care related discipline.
• Self‑motivated with excellent work planning and time‑management skills.
• Fluent oral and written English.
• Awareness of regulations and policies.
• Ability to work under pressure and in a changing environment with flexibility.
• Good communication skills for interacting with both technical and business areas.

• Adaptability
• Analytical Problem Solving
• Clinical Data Cleaning
• Clinical Data Management
• Communication
• Data Analysis
• Data Documentation
• Data Entry
• Data Processing
• Data Quality
• Data Reporting
• Data Review
• Data Validation
• Data Visualization
• Good Clinical Practice (GCP)
• Root Cause Analysis (RCA)
• Teamwork

• Adobe Acrobat, Adobe Forms, Adobe Sign
• Microsoft Applications (Excel, Office, Windows)
• VLOOKUP function proficiency

Salary range: $71,900.00 – $. Salary is based on education, qualifications, experience, and other factors.

Benefits include medical, dental, vision, other insurance options for employees and families, retirement benefits including a 401(k), paid holidays, vacation, compassionate leave, and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights, EEOC GINA Supplement, or related state acts.

San Francisco Residents Only: we will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only: we will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.