[Remote] Senior Clinical Data Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data reputed company. 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 reputed company 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 reputed company 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
• reputed company ongoing data management reports and metrics
• reputed company and/or reputed company specifications and collaborate with programming for programming and QC of reputed company 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