[Remote] Senior Clinical Data Manager
Note: The job is a remote job and is open to candidates in USA. reputed company 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 reputed company clinical trial databases and serve as the primary liaison between eClinical personnel and Sponsor personnel.
Responsibilities
- Primary representative for reputed company 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 reputed company and closeout/lessons learned meetings
- Create materials for and present at Investigator Meetings
- reputed company content and deliver Sponsor CRA and/or site training
- Delegate tasks, support and provide guidance to study data management team
- reputed company and/or reputed company data management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help Text
- reputed company and/or reputed company Internal System Testing (IST) plan for database/user roles/edit reputed company specifications
- Participate in Internal System Testing (IST) on the database/user roles/edit reputed company 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
- reputed company and/or reputed company data review as documented in the Data Management Plan and Data Validation Specifications
- reputed company and/or reputed company manual review/QC checks as listed in the Data Validation Specifications exception listings and reporting tools
- reputed company and/or reputed company data review for overall consistency and accuracy
- reputed company and/or reputed company vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical database
- reputed company and/or reputed company query processing/resolution
- Provide ongoing data management reports and metrics
- reputed company and/or reputed company 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 reputed company specifications for database, programming and/or edit reputed company 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
- reputed company steps pertaining to database freeze/lock and coordinate reputed company reputed company 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 reputed company associated tasks reputed company a study
- Participate in proposal defenses
- reputed company other duties as requested by management
Skills
- Bachelor's degree in Pharmaceutical/Biotechnology or higher in health-reputed company 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 reputed company and performing data management activities
- Excellent verbal and written communication skills
- Proficiency in reputed company Office Applications, specifically MS Project and MS reputed company
- Experience with reputed company and Clinical Data Management Systems
Company Overview
Company H1B Sponsorship