eClinical Solutions ยท 2 weeks ago
Senior Clinical Data Manager
United States
Full-time
Remote
Senior Level, Lead/Staff
$100K/yr - $125K/yr
8+ years expeClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. As a Senior Clinical Data Manager, you will oversee, maintain, and manage clinical trial databases, acting as the primary liaison between eClinical personnel and Sponsor personnel.
AnalyticsHealth CareInformation TechnologyPharmaceuticalProfessional ServicesSoftware
Responsibilities
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
Qualification
Preferred
Bachelor's degree in Pharmaceutical/Biotechnology or higher in health-related field
8+ years in Clinical Data Management experience
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
Company
eClinical Solutions
eClinical Solutions is a data intelligence hub.it transforms the way clinical data integration, aggregation, and analytics.
201-500 employees
H1B Sponsorship
eClinical Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (7)
2023 (8)
2022 (5)
2021 (5)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
GI PartnersSummit Partners
2024-09-12Private Equity
2024-09-12Acquired
2020-01-21Private Equity
Leadership Team
Raj Indupuri
CEO
Sam Anwar
Chief Technology Officer
Recent News
Business Wire
2025-12-10
2025-10-13
Company data provided by crunchbase