Analyst II Global Data Manager (Mumbai/Bangalore/Hyderabad)

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:
Mumbai, Maharashtra, India

Job Description:

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.

This position may be specialized into the following roles based on business needs: Global Data Manager (GDM), Clinical Data Manager (CDM)
Global Data Manager role-specific responsibilities:
•Perform trial level oversight controls and/or execute data management activities per applicable procedures, with DML direction.
Clinical Data Manager role-specific responsibilities:
•Perform (complex) scientific study data review and management of CDM, Study Responsible Scientist (SRS, and Study Responsible Physician related queries in EDC system.

Involvement in other clinical data review...