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Jobs via Dice

Central Monitoring Specialist

Jobs via Dice · United States

  • Hybrid
  • Full-time
  • $95,000 / year
  • United States
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Job highlights

  • Analyze clinical data and monitor study progress.
  • Develop and implement monitoring strategies.
  • Identify risks and ensure compliance.
  • Collaborate with cross-functional teams.
  • Support audits and regulatory requirements.

About the role

Clinical Data Analyst / Central Monitoring Specialist

Apetan Consulting, a client of Dice, is seeking a Clinical Data Analyst / Central Monitoring Specialist for a remote 6-month contract-to-hire position. This role is open to candidates in Arizona, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Massachusetts, Maryland, North Carolina, Tennessee, Virginia, and West Virginia.

Must Have:

  • 3+ years of Centralized Monitoring experience in a CRO or Clinical Research environment.
  • Prior experience as a Clinical Research Associate (CRA).
  • Hands-on experience with: Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), Central Monitoring Plans, Risk-Based Quality Management (RBQM), Data dashboard review, signal detection, and risk analysis.
  • Strong understanding of ICH, Google Cloud Platform, and FDA regulations.
  • Experience with clinical data systems, dashboards, Power BI, Tableau, SAS, SQL, R, or Python is a plus.

Preferred:

  • Experience in Oncology, Infectious Disease, or Government-sponsored studies.
  • Experience mentoring junior team members and improving monitoring processes.

Responsibilities:

  • Develop and manage KRIs, QTLs, and centralized monitoring strategies.
  • Review study data and dashboards to identify risks, trends, and compliance issues.
  • Support risk assessments and site performance monitoring.
  • Collaborate with Clinical Operations, Data Management, and Analytics teams.
  • Maintain risk logs and recommend corrective actions.
  • Support audits, inspections, and regulatory compliance.

Key skills/competency:

  • Centralized Monitoring
  • Clinical Data Analysis
  • Risk-Based Quality Management (RBQM)
  • Key Risk Indicators (KRIs)
  • Quality Tolerance Limits (QTLs)
  • Clinical Research Associate (CRA)
  • ICH Guidelines
  • FDA Regulations
  • Data Dashboards
  • Risk Analysis

Skills & topics

  • Clinical Data Analyst
  • Central Monitoring Specialist
  • CRO
  • Clinical Research
  • CRA
  • RBQM
  • KRI
  • QTL
  • Data Analysis
  • Risk Management
  • ICH
  • FDA
  • Power BI
  • Tableau
  • SAS
  • SQL
  • R
  • Python
  • Remote

How to get hired

  • Tailor your resume: Highlight your Centralized Monitoring, CRA experience, and specific skills like KRIs and RBQM.
  • Showcase data skills: Emphasize your experience with data systems, dashboards, and analytics tools such as Power BI, Tableau, SAS, SQL, R, or Python.
  • Understand regulations: Demonstrate your knowledge of ICH and FDA regulations relevant to clinical research.
  • Apply strategically: Mention your interest in contract-to-hire roles and your willingness to work remotely within the specified states.

Technical preparation

Master KRIs, QTLs, and RBQM principles.,Practice data dashboard review and signal detection.,Familiarize with ICH and FDA regulations.,Review clinical data systems and relevant software.

Behavioral questions

Describe a complex data risk you identified.,How do you collaborate with clinical operations?,How do you mentor junior team members?,How do you ensure regulatory compliance?

Frequently asked questions

What are the primary responsibilities for a Clinical Data Analyst / Central Monitoring Specialist at Apetan Consulting?
As a Clinical Data Analyst / Central Monitoring Specialist, your main duties will involve developing and managing Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), reviewing study data and dashboards to spot risks and trends, supporting risk assessments, and collaborating with various internal teams to ensure compliance and effective monitoring strategies. You will also assist with audits and inspections.
What experience is essential for the Clinical Data Analyst / Central Monitoring Specialist role?
The essential experience for this role includes at least 3 years of Centralized Monitoring in a CRO or clinical research setting, prior experience as a Clinical Research Associate (CRA), and hands-on work with KRIs, QTLs, Central Monitoring Plans, RBQM, and data dashboard review for signal detection and risk analysis. A strong understanding of ICH and FDA regulations is also critical.
Is this Clinical Data Analyst / Central Monitoring Specialist position remote, and what states are eligible?
Yes, this is a fully remote position. Eligible states for this role include Arizona, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Massachusetts, Maryland, North Carolina, Tennessee, Virginia, and West Virginia.
What is the employment type and duration for the Clinical Data Analyst / Central Monitoring Specialist position?
This position is a 6-month contract-to-hire role, offering an opportunity to transition into a permanent position with Apetan Consulting based on performance and business needs.
Are there any preferred qualifications for the Clinical Data Analyst / Central Monitoring Specialist role?
Preferred qualifications include experience in Oncology, Infectious Disease, or Government-sponsored studies. Additionally, experience mentoring junior team members and contributing to the improvement of monitoring processes would be beneficial.
What technical skills or tools are important for this Clinical Data Analyst / Central Monitoring Specialist position?
While hands-on experience with clinical data systems and dashboards is required, proficiency with tools like Power BI, Tableau, SAS, SQL, R, or Python is considered a plus for this Clinical Data Analyst / Central Monitoring Specialist role. A strong understanding of data analysis and risk detection is key.