Senior Clinical Data Associate
Location: Mumbai, Maharashtra, India
Work Mode: Fully Remote / Hybrid / Office-Based
Employment Type: Full-Time
Job ID: R-01331303
Category: Clinical Research | Clinical Data Management
About the Role
We are hiring a Senior Clinical Data Associate (Sr. CDA) to support global clinical research programs within a leading contract research organization (CRO). This role offers the opportunity to work on high-impact clinical studies while collaborating with cross-functional, international teams to ensure the integrity, accuracy, and regulatory compliance of clinical trial data.
As a Senior Clinical Data Associate, you will function as a key supporting data manager across one or more clinical projects, contributing to database setup, data cleaning, reconciliation activities, and process improvements. The position requires strong expertise in clinical data management, a proactive mindset, and the ability to manage complex datasets in accordance with global regulatory standards.
Key Responsibilities
Clinical Data Management Operations
Support study setup activities including database design, CRF development, data entry screen testing, and Data Validation Manual (DVM) creation.
Perform advanced data cleaning activities in compliance with GCP, global SOPs, and work practice documents (WPDs).
Identify, analyze, resolve, and document data discrepancies within clinical data management systems.
Generate, track, and resolve data queries and clarifications in coordination with internal teams and external stakeholders.
Data Review, Reconciliation & Reporting
Review data listings for accuracy, consistency, and protocol compliance.
Perform Serious Adverse Event (SAE) reconciliations and third-party vendor reconciliations.
Analyze and resolve data validation reports and other data management outputs.
Prepare and deliver project-specific status reports for Clinical Data Management (CDM) leadership and clients.
Leadership & Process Improvement
Act as a subject matter expert for study-specific or specialized data management processes.
Provide training, guidance, and work direction to junior clinical data associates as required.
Contribute to the continuous improvement of global data management processes and standards.
Support or lead complex assignments requiring independent judgment and problem-solving.
Cross-Functional Collaboration
Communicate effectively with global teams, investigators, vendors, and internal stakeholders.
Participate in planning and execution of communications that may require negotiation, persuasion, and stakeholder alignment.
Maintain strict confidentiality of clinical, patient, and proprietary data at all times.
Education & Experience Requirements
Bachelor’s degree or equivalent academic qualification in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related discipline.
Minimum of 3+ years of hands-on experience in Clinical Data Management or a closely related clinical research function.
A combination of relevant education, training, and professional experience may be considered in lieu of formal degree requirements.
Required Skills & Competencies
Strong knowledge of clinical trial processes, protocols, and data validation principles.
Proven experience with clinical data management systems, particularly Medidata Rave and Veeva Vault.
Familiarity with good documentation practices, including eTMF.
High attention to detail with strong numerical, analytical, and problem-solving abilities.
Excellent written and verbal communication skills with a strong command of English.
Proficiency in Microsoft Office and interactive clinical data tools.
Ability to work independently with moderate supervision and manage multiple priorities effectively.
Fast learner with the ability to adapt to new technologies, including Generative AI tools used in clinical research environments.
Strong interpersonal skills, cultural awareness, and experience working with global, cross-functional teams.
Work Schedule & Conditions
Working Hours: 1:00 PM to 10:00 PM IST (Monday to Friday)
Work Environment: Office-based, remote, or hybrid options available
Adherence to applicable Good Manufacturing Practices (GMP), GCP guidelines, and safety standards is required
Why Join Us
This role provides an opportunity to contribute to meaningful clinical research that advances patient care globally. You will be part of a high-performing, science-driven organization committed to innovation, quality, and professional growth within the clinical research and data management domain.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Rangpo |India :
Siliguri |Illinois :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Surabaya |Japan :
Saitama | Japan |Tokyo :
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Remote Korea |Republic of Korea :
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Ciudad de México | New Mexico |Dubai :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |