Senior Clinical Data Manager

Role Overview

• Primary representative for eClinical Solutions and sponsor data management interaction
• Responsible for monitoring and ensuring adherence to study timelines and deliverables
• Accountable for the overall quality of data management activities and deliverables at the study or program level
• Ensure efficiency and consistency for data management tasks across programs
• Communicate with global study teams
• Participate in client study kickoff and closeout/lessons learned meetings
• Create materials for and present at Investigator Meetings
• Develop content and deliver Sponsor CRA and/or site training
• Delegate tasks, support and provide guidance to study data management team
• Oversee and/or develop data management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help Text
• Oversee and/or Develop Internal System Testing (IST) plan for database/user roles/edit check specifications
• Participate in Internal System Testing (IST) on the database/user roles/edit check specifications
• Assist with preparation for implementation of a centralized data management platform for strategic data cleaning and reporting
• Utilization of centralized data management platform including graphical patient profiles and operational analytics
• Compile the sponsor UAT package
• Oversee and/or perform data review as documented in the Data Management Plan and Data Validation Specifications
• Oversee and/or perform manual review/QC checks as listed in the Data Validation Specifications exception listings and reporting tools
• Oversee and/or perform data review for overall consistency and accuracy
• Oversee and/or perform vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical database
• Oversee and/or perform query processing/resolution
• Provide ongoing data management reports and metrics
• Oversee and/or develop specifications and collaborate with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study
• Define and develop specifications for database, programming and/or edit check changes as needed throughout the study
• Track data management issues and ensure follow up to resolution
• Identify data issues and/or data trends, communicate to the Clinical Data Management team and Sponsor, assist with development and implementation of action plan
• Maintain data management study documentation
• Perform steps pertaining to database freeze/lock and coordinate all related activities
• Ongoing evaluation of process and participate in process improvement
• Assist in the creation and review of SOPs, WIs, and training materials
• Mentor junior level staff and peers on all associated tasks within a study
• Participate in proposal defenses
• Perform other duties as requested by management

Requirements

• Bachelor’s degree in Pharmaceutical/Biotechnology or higher in health-related field preferred
• 8+ years in Clinical Data Management experience preferred
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology
• Strong project management experience and project team leadership skills including work planning and work delegation
• Experience with EDC and performing data management activities
• Excellent verbal and written communication skills
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• Experience with EDC and Clinical Data Management Systems

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• 401(k) matching
• Paid time off
• Flexible work arrangements
• Professional development opportunities