eClinical Solutions logo
eClinical Solutions

We bring people and data together to support tomorrow’s breakthroughs

Senior Clinical Data Manager

Data ScientistData ScientistFull TimeRemoteSeniorTeam 201-500Since 2012H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

67 days ago

Salary

$100K - $125K / year

Seniority

Senior

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Clinical Data Manager

eClinical Solutions

• 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

Job 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

Benefits

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

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