Clinical Data Management Specialist

Job Title: Clinical Data Management Professional

We are seeking an experienced Clinical Data Management Professional to join our team. As a key member of our clinical data management team, you will be responsible for managing end-to-end clinical data management tasks, ensuring high-quality data delivery, and collaborating with cross-functional teams.

About the Role:

• Study Startup:
  
  • Draft EDC build timelines in collaboration with Data Management Leads.
    
  • Perform DB build tasks by creating specifications for Database and Edit Checks.
    
  • Create test scripts and complete test data entry/UAT for Coding, Site Payment, Safety Gateway.
    
  • Collaborate with Data Management Leads and facilitate startup meetings, including EDC build kick-off, Interactive eCRF Build, and IRMs (Interactive Review Meetings) for database and Edit checks.
    
  • Create and finalize study documents like Data Quality Management Plans, eCRF completion instructions, Protocol Data Review Plans (PDRPs) post-study team reviews.
    
  • E nsure all startup documents are completed as per SOP and filed in eTMF as per eTMF master plans.
  
  
  • Study Conduct:
    
    • Plan and execute Post-Production/Migration for studies (if applicable).
      
    • Coordinate with Clinical Data Managers for data review tasks execution.
      
    • Coordinate with external data vendors for escalations related to vendor data.
      
    • S upport Clean Patient Group deliveries alongside Clinical Data Management staff.
      
    • Update study documents as needed during study conduct.
      
    • Support DMLs (Data Management Leads) in conducting Data Quality Review meetings.
      
    • Provide Data Health Metrics to Data Management Leads as requested.
    
    
    • Study Closeout:
      
      • Support Data Management Leads in planning and executing database lock activities.
        
      • Perform post-lock activities as needed.
      
      
      • Project Management:
        
        • Support DMLs in project management tasks to ensure successful study delivery within timelines and quality standards.
        
        
        • Documentation:
          
          • F iling of appropriate documents in eTMF as per eTMF master plans.
          
          
          • Training and Mentorship:
            
            • P rovide training and mentoring to junior CDM staff.
            
            

Requirements:

• Bachelor's Degree required.
  
• Life sciences, pharmacy, or relevant fields preferred.
  
• 6 years of experience in managing end-to-end Clinical Data Management tasks.
  
• Able to work on end-to-end Clinical Data Management tasks.
  
• Able to collaborate with multi-disciplinary project teams.
  
• Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines, and industry standard practices regarding data management.
  
• Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills.
  
• Strong oral and written communication skills.
  
• Strong project management skills.
  
• Affirmative response to attending 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed).

About Our Culture:

We recognize the importance of balance and flexibility in our work environment. We offer a wide range of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives.

Occupancy Structure:

We have an occupancy structure that determines where an employee is required to conduct their work. This includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type assigned is determined by the nature and responsibilities of the role. Site-essential roles require 100% onsite presence at assigned facilities.

Workplace Accommodations:

We are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles.