By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
ScienceabodeScienceabode
  • Home
  • News & Perspective
    News & PerspectiveShow More
    Microorganism that causes rare but severe eye infections detected in NSW coastal areas
    By Admin
    Scientists identify common cause of gastro in young children and adults over 50 years old
    By admin
    AI reveals hidden traits about our planet’s flora to help save species
    By admin
    Eye drops slow nearsightedness progression in kids, study finds
    By admin
    Using AI to create better, more potent medicines
    By admin
  • Latest News
    Latest NewsShow More
    Researchers develop new robot medics for places doctors are unable to be
    By Admin
    Even thinking about marriage gets young people to straighten up
    By admin
    Study: People tend to locate the self in the brain or the heart – and it affects their judgments and decisions
    By admin
    UCLA patient is first to receive successful heart transplant after using experimental 50cc Total Artificial Heart
    By admin
    Via Dying Cells, UVA Finds Potential Way to Control Cholesterol Levels
    By admin
  • Health
    Health
    The World Health Organization defines health as “a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”…
    Show More
    Top News
    World’s largest study of brain volume reveals genetic links to ADHD, Parkinson’s Disease 
    October 26, 2024
    Chemicals produced by fires show potential to raise cancer risk
    November 11, 2024
    Rising rates of head and neck cancers in England
    October 26, 2024
    Latest News
    Perfumes and lotions disrupt how body protects itself from indoor air pollutants
    June 3, 2025
    Medical Milestone: Surgeons Perform First-Ever Human Bladder Transplant
    May 20, 2025
    A Downside of Taurine: It Drives Leukemia Growth
    May 19, 2025
    How do therapy dogs help domestic abuse survivors receiving support services?
    May 10, 2025
  • Environment
    EnvironmentShow More
    Perfumes and lotions disrupt how body protects itself from indoor air pollutants
    By Admin
    Arsenic exposure linked to faster onset of diabetes in south Texas population 
    By Admin
    Antarctica vulnerable to invasive species hitching rides on plastic and organic debris
    By Admin
    New substrate material for flexible electronics could help combat e-waste
    By Admin
    Bacteria ‘nanowires’ could help scientists develop green electronics
    By Admin
  • Infomation
    • Pricavy Policy
    • Terms of Service
  • Jobs
  • Application Submission
Notification Show More
ScienceabodeScienceabode
  • Home
  • Health
  • Anatomy
  • Jobs Portal
  • Application Submission
  • Categories
    • Health
    • Anatomy
    • Food & Diet
    • Beauty Lab
    • News & Perspective
    • Environment
  • More Foxiz
    • Blog Index
    • Sitemap
Follow US
Scienceabode > Senior Clinical Data Manager

Senior Clinical Data Manager

Last updated: 2025/05/29 at 8:10 AM
By
Share
3 Min Read
SHARE
  • Permanent
  • United States
  • Posted 5 days ago
Katalyst Healthcares & Life Sciences

Website Katalyst Healthcares & Life Sciences

Katalyst Healthcares & Life Sciences

Company : Katalyst Healthcares & Life Sciences

Responsibilities:

Support the Lead Data Manager across one or more clinical studies.

Reviews protocols for appropriate data capture including electronic (eCRF) design.

Support CRF design, review, and validation of clinical database.

Provide expertise and support oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.

Reviews or generates study documents (Data Management Plan, CRF Completion Guidelines, DB build specifications, Edit Check Specifications, Data Transfer Specifications, SAE and/or External Data Reconciliation Plans, Coding Guidelines, Vendor Management Plans, etc.).

Review CRF metrics reports against project data deliverables.

Conducts oversight of data management vendors via ongoing review of quality and performance metrics.

Leads the Data Review plan check, specification and validation updates.

Facilitates and participates in scheduled and ad hoc data listing review.

Generates, resolves, and tracks data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications.

Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.

Reviews and provides feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.

Maintains study DM related documents/files for inspection readiness.

Conducts the SAE and external vendor data reconciliation.

Review and may distribute/coordinate data management metrics, listings, and reports.

Responsible for maintaining internal data management timelines and metrics. Maintains study DM related documents/files for inspection readiness.

Proactively identifies potential data management issues/risks and communicates it within the study team for further action.

Participate in process improvement activities resulting in increases in productivity, quality, and/or cost effectiveness.

Requirements:

Minimum BA/BS in scientific or health-related field.

Minimum of 9-11 years of clinical data management experience in the pharmaceutical, and biotechnology industry or in a CRO.

At least 1 year experience working at a Sponsor.

Oncology trial experience required, hematology/oncology preferred.

Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to DM practice.

Proficient with Medidata RAVE.

Experience with working on Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.

Familiarity with various data visualization, analytics, and reporting tools is a plus

Excellent communication skills (verbal and writing).

Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting.

Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.)

Strong organizational skills and ability to prioritize tasks.

Proven ability to work independently and in a team setting.

Share This Article
Facebook Twitter Copy Link Print

Fast Four Quiz: Precision Medicine in Cancer

How much do you know about precision medicine in cancer? Test your knowledge with this quick quiz.
Get Started
Even in Winter, Life Persists in Arctic Seas

(USCGC Healy breaking through the Bering Sea waves. Credit: Chantelle Rose/NSF)   Despite…

A Biodiversity Discovery That Was Waiting in the Wings–Wasp Wings, That Is

Wing size differences between two Nasonia wasp species are the result of…

Entertainement

Coming soon

Your one-stop resource for medical news and education.

Your one-stop resource for medical news and education.
Sign Up for Free

You Might Also Like

QA Tester

By

Travel Clinical Lab Scientist (CLS) – $2,307 per week

By

Quality Assurance Associate

By

Quality Assurance Manager

By
Facebook Twitter Youtube Instagram
Company
  • Privacy Policy
  • Editorial Policy
  • Accessibility Statement
  • Contact US
  • Feedback
  • Advertisement
More Info
  • Newsletter
  • Beauty Lab
  • News & Perspective
  • Food & Diet
  • Health
  • Environment
  • Anatomy

Sign Up For Free

Subscribe to our newsletter and don't miss out on our programs, webinars and trainings.

Copyright © 2023 ScienceAbode. All Rights Reserved. Designed and Developed by Spirelab Solutions (Pvt) Ltd

Welcome Back!

Sign in to your account

Lost your password?