Analyst II Clinical Data Manager - Hyderabad/Bangalore/Mumbai
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Key skills for this role
About the Role
Johnson & Johnson Innovative Medicine seeks an Analyst II Clinical Data Manager for Hyderabad/Bangalore/Mumbai. The role provides oversight and executes data management activities for clinical trials.
Key Skills for This Role
Responsibilities
- Take a leadership role with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management expectations
- Gather and/or review content and integration requirements for eCRF and other data collection tools
- Establish conventions and quality expectations for clinical data
- Establish expectations for dataset content and structure
- Set timelines and monitor delivery of all data management milestones
- Review clinical data management documents ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency
- Ensure real time inspection readiness of all DM deliverables and participate in regulatory agency and J&J internal audits
- Plan and track content, format, quality, and timing of applicable data management deliverables
- Take a leadership role with the assigned clinical working group(s) to ensure DM and TA trial needs and deliverables are achieved
- Create key functional plans (e.g. study Integrated Review Plan)
- 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
Requirements
- Bachelor's degree (BS, BA) or equivalent professional experience, preferably in Clinical Data Management, Health, or Computer Sciences
- Approx. 2+ years of experience in Pharmaceutical, CRO or Biotech industry or related field
- 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)
Full Job Posting
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 tria
- This position analyzes and provides input into decisions with direction from manager or Data Management Leader (DML).
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
- Gather and/or review content and integration requirements for eCRF and other data collection tools
- Establish conventions and quality expectations for clinical data
- Establish expectations for dataset content and structure
- 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 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
- 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)
- 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
Required Education and Experience
- Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences
- 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 Qualifications
- 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
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