Analyst II Global Data Manager (Bangalore/Mumbai/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

Data Analytics & Computational Sciences

Clinical Data Management

Professional

Bangalore, Karnataka, India

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 activities (e.g., Coding, SAE reconciliation) is possible.
  
• Collaborate with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.
  

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.