ANALYST II – CLINICAL DATA MANAGER
Company: Johnson & Johnson
Location: Hyderabad / Bangalore / Mumbai, India
Department: Clinical Data Management
Job Function: Data Analytics & Computational Sciences
Job Type: Full-Time
Work Model: Hybrid
JOB OVERVIEW
Johnson & Johnson is seeking an Analyst II Clinical Data Manager to provide oversight and execution of clinical data management activities across multiple clinical trials. The role involves managing data collection processes, ensuring data quality and regulatory compliance, collaborating with internal and external stakeholders, and supporting clinical trial data review and management activities.
KEY RESPONSIBILITIES
Lead interactions with external suppliers, CROs, trial teams, and internal stakeholders to establish clinical data management expectations.
Gather, review, and manage requirements for eCRFs and other clinical data collection tools.
Establish clinical data quality standards, conventions, and expectations.
Define dataset content and structure requirements.
Monitor and track clinical data management milestones and deliverables.
Review clinical data management documentation and submission packages for accuracy, consistency, and regulatory compliance.
Ensure inspection readiness of all clinical data management deliverables.
Participate in regulatory inspections, audits, and internal quality reviews.
Develop and maintain study-specific functional plans such as Integrated Review Plans.
Collaborate with clinical working groups to ensure trial data requirements are met.
Support scientific data review and management of Study Responsible Scientist (SRS) and Study Responsible Physician (SRP) queries in EDC systems.
Participate in coding reviews, SAE reconciliation, and other clinical data review activities.
Identify lessons learned, best practices, and process improvements.
Contribute to clinical data management systems, process, and tool enhancement initiatives.
TECHNICAL SKILLS
Clinical Data Management (CDM)
Electronic Data Capture (EDC)
eCRF Design and Review
Clinical Data Review
Query Management
SAE Reconciliation
Medical Coding Oversight
Clinical Trial Data Validation
Data Quality Management
Clinical Database Review
Inspection Readiness
Vendor and CRO Management
Clinical Trial Documentation
REGULATORY KNOWLEDGE
Good Clinical Practice (GCP)
ICH Guidelines
FDA Regulations
EMA Regulations
Clinical Trial Compliance
Regulatory Submission Requirements
Data Integrity Standards
Audit and Inspection Readiness
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Statistics, Data Science, or related field
Preferred
Master's Degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related discipline
EXPERIENCE
Typically 3–6 years of Clinical Data Management experience.
Experience managing low to moderate complexity clinical trials.
Experience with EDC systems and clinical trial databases.
Experience working with CROs and external vendors.
Knowledge of clinical trial processes and data review activities.
Experience in query management and data cleaning activities preferred.
Uttar Pradesh :
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Hajipur | Patna |Kerala :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
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Basel | Zurich |Serbia :
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Budapest |BULGARIA :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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China | Quarry Bay |Liaoning :
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Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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South Yarra |United Kingdom :
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Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Renfrew | Uxbridge | Mississauga | North York | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Bangkok |Israel :
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Prague |Chile :
Santiago |Bosnia and Herzegovina :
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