Lead Clinical Data Manager

URGENT NEED FOR CLINICAL DATA MANAGERS - 100% REMOTE!

Description:

The Lead Clinical Data Manager is responsible for data management oversight activities for research studies and works as an integral part of a cross-functional team through the lifecycle of the research study from design through final analysis and study closeout

Also responsible for the completeness and accuracy of the study data in the electronic database and serves as primary point of contact with internal and external project teams on all aspects of data collection

Collaborates with cross-functional teams and facilitates the design, documentation, testing and implementation of clinical data collection studies in an electronic data capture (EDC) system

Creates and/or reviews study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards

Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner

Determines data collection requirements based on the study protocol and system knowledge, makes recommendations based on previous experience

Proactively identifies potential data management issues/risks and recommends/implements solution

Manages data collection and data validation at participating clinical sites

Manages training documentation and provides oversight of system user access, may serve as resource for troubleshooting system issues

Creates and/or reviews study data management documents (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User’s Guide, EDC Training and Certification Documents)

Independently monitors own activities and project status for successful project deliverables according to timelines

Manages data reports and creates data summaries or presentations as applicable

Manages the development of the data validation plan and ensures associated edit checks are completed in accordance with project timelines

Manages and reconciles data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources

Performs data review and query identification/resolution, manages data quality metrics for a protocol or project

Attends and contributes to project and functional group meetings, may serve as DM representative on external calls as required

Mentors staff on project-specific clinical data management processes, provides data management expertise at a project level

May provide direct line support for DM staff

Collaboratively conducts performance and compensation review activities with the applicable project leader or designee

Responsible for addressing employee relations issues and resolving problems

Ensures DM salary and bonus equity compliance

Approves timesheets, expense reports, and leave requests

Additional Skills & Qualifications:

Basic understanding of the clinical development and data management processes; or equivalent combination of education and experience

Knowledge of MS Excel, Word, Access, and PowerPoint

Proven data management skills

Excellent verbal and communication skills

Self-motivated, reliable team member

Strong attention to detail and flexible

MUST HAVES:

Clinical Research experience - 5+ years of clinical data management experience

Please note: for this role, you must be legally authorized to work in the US or Canada. Employment verification and/or references will be required before interview process.