Job Title: Analyst II Clinical Data Manager - Hyderabad/Bangalore/Mumbai
Function: Data Analytics & Computational Sciences
Sub Function: Clinical Data Management
Category: Experienced Analyst, Clinical Data Management (P5)
Location: Hyderabad / Bangalore / Mumbai, India
Work Pattern: Hybrid Work
Requisition Number: R-002636
Date Posted: May 13, 2025
Company Overview:
At Johnson & Johnson, health is everything. We lead healthcare innovation to prevent, treat, and cure complex diseases. With expertise in Innovative Medicine and MedTech, we deliver smarter, less invasive treatments and personalized solutions, aiming to profoundly impact global health.
Learn more at https://www.jnj.com
Position Summary:
The Analyst II Clinical Data Manager is a junior-level professional contributor responsible for oversight and execution of data management activities, including scientific data review for multiple low-to-moderate complexity trials or one high complexity trial. The role involves providing recommendations, influencing decisions, and working with guidance from a Data Management Leader.
Principal Responsibilities:
Lead collaboration with external suppliers, trial customers, and internal/external partners to align data management expectations for assigned trial(s).
Gather and review requirements for eCRF and other data collection tools.
Establish conventions and quality standards for clinical data and datasets.
Set and monitor timelines for data management milestones.
Review clinical data management documents for quality, accuracy, consistency, and regulatory compliance.
Ensure real-time inspection readiness of all data management deliverables; participate in audits as required.
Plan and track content, format, quality, and timing of data management deliverables to ensure timely completion.
Lead clinical working groups to meet data management and therapeutic area trial needs.
Create key functional plans (e.g., Integrated Review Plan) ensuring clarity and scientific accuracy.
Identify and communicate lessons learned and best practices at the trial level.
Participate in process, system, and tool improvement initiatives.
Clinical Data Manager Role-Specific Responsibilities:
Perform complex scientific study data review and manage queries related to Clinical Data Management (CDM), Study Responsible Scientist (SRS), and Study Responsible Physician (SRP) within the Electronic Data Capture (EDC) system.
Collaborate closely with SRS/SRP to meet data management and therapeutic area deliverables.
Principal Relationships:
Reports to Data Management Leader or equivalent manager.
Collaborates with leaders and teams in Data Management, Clinical Programming, Clinical Data Standards, Regulatory Medical Writing, Therapeutic Area Leads, and system support.
Works with global program and trial leaders, biostatisticians, clinical teams, procurement, finance, legal, privacy, regulatory, strategic partnerships, HR, and project coordinators.
Engages with external partners, suppliers, CROs, vendor liaisons, and industry working groups.
Education and Experience Requirements:
Required:
Bachelor’s degree (BS, BA) or equivalent professional experience, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (Master’s, PhD).
Approximately 5+ years of experience in Pharmaceutical, CRO, Biotech, or related industry.
Experience in clinical drug development and cross-functional team collaboration.
Strong written and verbal communication skills in English.
Preferred:
Team leadership experience.
Clinical data management expertise and understanding of clinical trial protocols.
In-depth knowledge of clinical drug development processes and international data management guidelines.
Familiarity with technology platforms for data capture and processing, and understanding of data privacy in clinical data exchange.
Additional Information:
Approximately <10% domestic or international travel may be required.
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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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Kyiv |Lima Region :
Lima |France :
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Niš |Bohemia :
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