[Remote] Senior Clinical Data Manager
Note: The job is a remote job and is open to candidates in USA. eClinical 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 clinical trial databases and serve as the primary liaison between eClinical personnel and Sponsor personnel.
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
Skills
- 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
Company Overview
Company H1B Sponsorship