Work as Global Data Management Specialist at Johnson & Johnson

Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world.

Post : Global Data Management Specialist

Job Description
Position Summary
Type of Role : This is a professional individual contributor role that provides oversight and accountability for multiple low, moderate, and high complexity trials. May be a member of multiple projects of low, moderate, high complexity or a leader of projects of low to moderate complexity.

Principal Responsibilities
• Takes a leadership role with the CRO, the trial customer(s), GDM and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s). Identifies and communicates ways to improve deliverables.
• With the trial customer, CRO, GDM, and other functional partners: – Takes a leadership role to gather content and integration requirements for eCRF and other data collection tools. – Leads conventions and quality expectations for clinical data. – Leads expectations for dataset content and structure. – Sets timeline and follow-up regularly to ensure delivery of all data management milestones.
• Ensures trial level oversight controls are performed as described in the oversight plan, QC process, and work instructions.
• Ensures that clinical data management documents are reviewed accurately (including submission package) to facilitate appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
• Oversees the assessment of real-time inspection readiness of all DM deliverables for the trial. Participates in regulatory agency and J&J internal audits as necessary.
• Leads the planning and tracking of content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.
• Takes a leadership role with the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are met. Collaborates with the DML to develop scope of work and identify needed resources. Works with Infrastructure Organization to ensure all deliverables are effectively completed.
• Takes a leadership role to obtain and share best practices with internal partners. Leads others in implementing process, system, and tool improvement initiatives within DM.
• Presents information and trains investigator and site monitors.
• May undertake the principal responsibilities of a CDM, as appropriate.

Candidate Profile
Education and Experience Requirements
• BA/BS degree or professional experience equivalent
• Data management experience
• Experience in clinical drug development within the pharmaceutical industry or related industry
• Vendor oversight experience
• Team leadership experience
• Project management experience

Desired Experience :
• 2 years of experience in therapeutic area
• 3 years of experience as a Senior Global Data Manager

Additional Information
Experience : 2 to 3 years
Education : BA/BS degree or professional experience
Location : Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 25th March, 2024