Senior Clinical Data Manager

Overview

A Senior Clinical Data Manager is responsible for performing data management activities for studies in a manner that ensures all time frames and targets are met to the client’s satisfaction. These activities include all aspects of data management from study startup through database lock including document creation, database testing, and data cleaning.

 

A Senior Clinical Data Manager may be responsible for the quality and accuracy of the database for multiple clinical studies across multiple indications/sponsors. 

Responsibilities

  • Follow Standard Operating Procedures (SOPs)
  • Communicate with the study team
    • Create documentation for and conduct regularly scheduled meetings
    • Coordinate with the applicable programming team regarding any database or programming changes needed throughout the study
    • Coordinate with all applicable external vendors
    • Direct sponsor/client representative interaction
  • Participate in client study kickoff and closeout meetings
  • Create materials for and, if necessary, conduct kick-off meetings and study specific trainings
  • Perform Study Start-up
    • Prepare or review draft Case Report Forms (CRFs)
    • Prepare draft of CRF Completion Guidelines
    • Prepare draft of Data Management Plan (DMP) and Edit Check Specifications
    • Prepare draft of all applicable database design specifications
    • Prepare draft of User Acceptance Testing (UAT) Plan
    • Perform UAT on the database/user roles/edit check specifications and compile the UAT package
    • Review draft CRF Annotates and Database Specifications
  • Perform Data Management Review
    • Perform discrepancy management by effectively utilizing the DMP and Edit Check Specifications to review the data for overall consistency and accuracy
    • Perform manual review/QC checks as listed in the Edit Check Specifications using applicable browser or reporting tools
    • Perform vendor data reconciliation with applicable clinical database (e.g., IVRS, laboratory data, SAE)
    •  Perform query processing/resolution
    • Track all DM issues and ensure proper resolution by study completion
    • Identify data trends and report study inconsistencies to applicable study team personnel and work together to develop and implement an action plan
  • Assist with final Quality Control reviews and compile final Quality Control audit reports
  • Maintain and compile all study documentation
  • Perform steps pertaining to database freeze/lock and coordinate all related activities

 

Additional Responsibilities

  • Assist in the creation and review of SOPs and training materials
  • Ad hoc report creation and validation
  • Conduct data management applicable training for employees
  • Interview job applicants and provide feedback
  • Perform other duties as requested by management

Qualifications

At least 5 years of experience in data management is required and a Bachelor’s degree is preferred but not required. The candidate must be able to perform all job functions with minimal to no direct supervision and possess a full understanding of all aspects of data management.  In addition, the candidate must have excellent written, verbal and organizational skills.  They must be detail-oriented, a self-motivator, and proficient in Microsoft Office.  The candidate must be willing to take on additional projects and work overtime when necessary.

 

Minimum Training Requirements

The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:

  • Applicable Standard Operating Procedures
  • Good Clinical Practices (GCP Regulations; ICH Guidelines; Good Quality Practices)
  • 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidances; Computerized Systems Used In Clinical Trials)
  • Good Clinical Data Management Practices
  • HIPAA
  • Drug Development and Approval Process
  • Data Management Overview
  • MedDRA and WHODrug Overview
  • Sponsor/Study specific trainings, when applicable
  • Applicable system training


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