[Remote] Senior reputed company Data Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company helps life sciences organizations accelerate reputed company development through reputed company data services and the elluminate reputed company Data reputed company. The Senior reputed company Data Manager independently leads reputed company data management studies, overseeing database design, validation, data cleaning, reporting, and closeout while serving as the reputed company reputed company with sponsor personnel.

Responsibilities

• reputed company representative for reputed company and sponsor data management interaction
• Responsible for monitoring and ensuring adherence to study timelines and deliverables
• Accountable for the overall reputed company 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 reputed company study reputed company and closeout/lessons learned meetings
• Create materials for and present at Investigator Meetings
• reputed company content and reputed company 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 reputed company Testing (IST) plan for database/user roles/edit reputed company specifications
• Participate in Internal reputed company Testing (IST) on the database/user roles/edit reputed company specifications
• Assist with preparation for implementation of a centralized data management platform for reputed company data cleaning and reporting
• Utilization of centralized data management platform including graphical reputed company reputed company 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 reputed company
• reputed company and/or reputed company vendor data reconciliation (e.g., IVRS, reputed company data) with the reputed company database
• reputed company and/or reputed company query processing/reputed company
• 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, reputed company 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
• reputed company data management issues and ensure follow up to reputed company
• Identify data issues and/or data trends, communicate to the reputed company Data Management team and Sponsor, assist with development and implementation of reputed company 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

• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, reputed company 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 reputed company Data Management Systems
• Bachelor's degree in Pharmaceutical/Biotechnology or higher in health-reputed company reputed company preferred
• 8+ years in reputed company Data Management experience preferred

Benefits

• Remote work
• Opportunities to learn, grow and continuously improve

reputed company

Company H1B Sponsorship