Data Manager

Job Description

Responsibilities

• Primary representative for 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 

Take the first step towards your dream career. Here is what we are looking for in this role. 

Qualifications: 

• 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 

Are you interested in this position?
Apply by clicking on the “Apply Now” button below!
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