Lead Rave Clinical Data Manager

Company: Actalent
Location: Rockville
Posted on: September 19, 2022

Job Description:

Description:
The Senior 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
Skills:
Client Facing, Quality Control, Data Collection, Rave
Top Skills Details:
Client Facing,Quality Control,Data Collection,Rave
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
Experience Level:
Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Rockville , Lead Rave Clinical Data Manager, Executive , Rockville, Maryland