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Company

Emmes · 6 hours ago

Senior Data Manager

Rockville, MD

Full-time

Remote

Senior Level

6+ years exp

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BiopharmaBiotechnology

H1B Sponsor Likely

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Responsibilities

Coordinates the development of CDEs

Ensures communications from subject matter experts for CDE development and modifications are provided to the CDE team

Coordinates the updates of CDEs as defined by subject matter experts

Ensures the consolidation of disparate case report forms into a unified template

Collaborates with cross-functional teams and facilitates the development, documentation, and configuration of CDE data standards

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 department standards; works 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 solutions

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 or CDE representative on external calls as required

Mentors staff on CDE processes and standards and on project-specific clinical data management processes; provides data management and CDE expertise at a project level

May provide direct line support for CDE and 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

Other duties as assigned

Qualification

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Data ManagementClinical ResearchElectronic Data Capture (EDC)Clinical Practice (GCP)Pharmaceutical Industry ExperienceData ValidationMaster's DegreeRegulatory Guidelines KnowledgeMentoring Skills

Required

Bachelor’s degree, preferably in a public health, clinical, science, technical, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degree

Incumbent typically will possess at least 6+ years of progressive data management experience (or Master’s degree and 4 years) and good understanding of clinical research and/or data management processes

Knowledge of GCP and applicable regulatory guidelines

Preferred

Experience in pharmaceutical industry and/or contract research organization

Experience in clinical electronic data capture (EDC) systems

Benefits

Flexible Approved Time Off

Tuition Reimbursement

401k Retirement Plan

Work From Home Anywhere in the US

Maternal/Paternal Leave

Casual Dress Code & Work Environment

Company

Emmes

Glassdoor

3.6

Emmes is a contract research organization that offers clinical research services for public health and biopharmaceutical innovation.

Founded in 1977

Rockville, Maryland, USA

1,001-5,000 employees

https://www.emmes.com/

H1B Sponsorship

Emmes has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (5)

2022 (9)

2021 (8)

2020 (4)