Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Data Analytics & Computational Sciences Job Sub Function: Clinical Data Management Job Category: Professional All Job Posting Locations: IN004 Bangalore, IN020 Mumbai Arena Space, IN022 Hyderabad : 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