Clinical Data Associate II
Bangalore, Karnataka, India
R-01324178
Full-time
Clinical Research
Fully Remote
Second Shift (1:00 PM – 10:00 PM IST)
Must adhere to all Good Manufacturing Practices (GMP) and Safety Standards
This position is with Trialmed, a global site network and the early phase clinical solution for PPD, which is part of Thermo Fisher Scientific Inc. As part of our leading global contract research organization (CRO), our Clinical Research team powers the PPD® clinical research portfolio, addressing some of the world’s most critical health challenges.
As a Clinical Data Associate II (CDA II), you will support and lead data management tasks on one or more clinical projects. You’ll ensure the quality, integrity, and completeness of data, working closely with global teams in a highly regulated environment, contributing to the successful execution of clinical trials.
Identify and resolve data discrepancies; update data in the data management database.
Generate, track, and resolve data clarifications and queries.
Review data listings for accuracy, consistency, and compliance.
Implement CRF (Case Report Form) design using relevant graphic tools.
Prepare and deliver project-specific status reports for internal management and clients.
Conduct Serious Adverse Event (SAE) and third-party vendor data reconciliations.
Perform advanced data cleaning activities in compliance with GCPs and SOPs/WPDs.
Handle complex assignments that require judgment and initiative.
Suggest solutions or new procedures for data management improvements.
Communicate effectively with both internal stakeholders and external organizations.
May act as a team leader or independent contributor on assigned projects.
Bachelor’s degree or equivalent academic qualification.
Minimum of 2+ years of experience in clinical data management or related field.
Equivalent combination of education, training, and experience may be considered.
Strong understanding of regulatory guidelines, GCP, global SOPs, and client-specific requirements.
Proficient in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
Attention to detail with strong numerical, organizational, and analytical skills.
Excellent written and verbal English communication.
Experience working with EDC systems, especially Medidata Rave and Veeva Vault.
Familiarity with eTMF and good documentation practices.
Ability to interpret clinical trial protocols and Data Validation Manuals.
Capable of independently prioritizing tasks and meeting deadlines.
Fast learner with the ability to adapt to new tools, including Generative AI tools.
Effective team collaboration and cultural awareness in a global work environment.
Strong time management, customer focus, and confidentiality skills.
Comfortable working independently or as part of a team, showing good judgment in decisions.
Standard working hours: 1:00 PM – 10:00 PM IST
Flexible work options: Remote, Office-based, or Hybrid
Be part of our mission to make the world healthier, cleaner, and safer by applying your expertise in data management. Join Trialmed, a division of Thermo Fisher Scientific, and contribute to life-changing clinical research.
 
                      
                      
                     
                      
                      
                     
                      
                      
                     
                      
                      
                     
                      
                      
                     
                      
                      
                     
                      
                      
                     
                      
                      
                     
                      
                      
                     
                      
                      
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Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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China | Quarry Bay |Hubei :
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Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
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Sofia |Canada :
Canada |Ontario :
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Prague |Republic of Egypt :
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North Ostrobothnia :
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Japan | Saitama |Tokyo :
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