Analyst II Clinical Data Manager - Hyderabad / Bangalore / Mumbai

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 :

Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, Maharashtra, India

Job Description

Integrated Data Analytics and Reporting (IDAR)

Analyst II Clinical 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

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 :

collection tools.

milestones.

appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.

Ensure compliance with regulatory guidelines and the documentation matrix.

regulatory agency and J&J internal audits as necessary.

Ensure deliverables are on time.

needs and deliverables are achieved.

scientific content, organization, clarity, accuracy, format, and consistency.

trial level.

Clinical Data Manager Role-specific Responsibilities

Scientist (SRS, and Study Responsible Physician related queries in EDC system. Involvement

in other clinical data review activities (e.g., Coding, SAE reconciliation) is possible.

deliverables are achieved.

Principal Relationships

Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data

Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support

organizations.

limited to : Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams,

Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human

Resources and Project Coordinators.

and vendor liaisons, industry peers and working groups.

Required

Education and Experience Requirements :

Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (e.g.,

Master, PhD).

industry.

Preferred

clinical trial protocols.

clinical trials.

understanding of data privacy rules in relation to clinical data exchange.

Other

Approx.

Skills Required

Data Management, Clinical Data Management