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Job Function:
Data Analytics & Computational SciencesJob Sub Function:
Clinical Data ManagementJob Category:
ProfessionalAll Job Posting Locations:
Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, IndiaJob Description:
Integrated Data Analytics and Reporting (IDAR)
Analyst II Global Data Manager*
(*Title may vary based on Region or Country requirements)
Position Summary:
The Analyst II Data Manager is a professional individual contributor role at junior level that provides oversight and accountability and/or executes data management activities and/or performs scientific data review for more than one trial of low to moderate complexity or for one high complexity trial. The Analyst II Data Manager makes recommendations and influences decisions for specific trials or assignments.
This position analyzes and provides input into decisions with direction from manager or Data Management Leader (DML). Work is received in broad terms. Work is reviewed on an ongoing basis with Data Management Leader and the amount of instruction is limited.
Principal Responsibilities:
• Take a leadership role with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations to the business for assigned trial(s) to include but not limited to:
o Gather and/or review content and integration requirements for eCRF and other data collection tools.
o Establish conventions and quality expectations for clinical data.
o Establish expectations for dataset content and structure.
o Set timelines and follow-up regularly to monitor delivery of all data management milestones.
• Review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensure compliance with regulatory guidelines and the documentation matrix.
• Ensure real-time inspection readiness of all DM deliverables for the trial and participate in regulatory agency and J&J internal audits as necessary.
• Plan and track content, format, quality, and timing of applicable data management deliverables. Ensure deliverables are on time.
• Take a leadership role with the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are achieved.
• Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
• Identify and communicate lessons learned, best practices, and frequently asked questions at the trial level.
• Identify and participate in process, system, and tool improvement initiatives.
Global Data Manager role-specific responsibilities:
• Perform trial level oversight controls and/or execute data management activities per applicable procedures, with DML direction.
Principal Relationships:
• Reports into people manager position within functional area (e.g., Data Management Leader).
• Functional contacts within IDAR include but not limited to: Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations.
• Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but not limited to: Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources and Project Coordinators.
• External contacts include but not limited to: External partners and suppliers, CRO management and vendor liaisons, industry peers and working groups.
Education and Experience Requirements:
Required
• Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (e.g., Master, PhD).
• Approx. 2 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
• Experience in clinical drug development within the pharmaceutical industry or related industry.
• Experience working with cross functional stakeholders and teams.
• Strong written and verbal communications skills (in English).
Preferred
• Team leadership experience.
• Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols.
• In-depth knowledge of current clinical drug development processes.
• In-depth knowledge of applicable international guidelines regarding data management of clinical trials.
• Knowledge of technology platforms and systems to capture and process data as well as understanding of data privacy rules in relation to clinical data exchange.
Other: • Approx. <10% travel (domestic or international) may be required.
Required Skills:
Preferred Skills:
Advanced Analytics, Biostatistics, Business Behavior, Clinical Data Management, Clinical Operations, Communication, Cross-Functional Collaboration, Database Applications, Data Privacy Standards, Data Savvy, Good Clinical Practice (GCP), Organizing, Problem Solving, Report Writing, Standard Operating Procedure (SOP), Systems AnalysisJohnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
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