Senior Data Scientist designing generative AI applications at Roche, leveraging extensive expertise in AI and business applications. Collaborating with teams and influencing technical priorities in a dynamic environment.
About the role
- Senior Data Manager at Johnson & Johnson overseeing clinical data management for trials. Leading external partnerships and ensuring compliance with regulatory guidelines within a hybrid work environment.
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).
- 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.
- Ensure accurate review of related clinical data management documents as well as compliance with regulatory guidelines and documentation requirements.
- Ensure real-time inspection readiness of all DM deliverables for the trial; participate in Regulatory Agency and J&J internal audits as necessary.
- Lead the planning and tracking of content, format, quality, and timing of applicable data management deliverables. Ensure deliverables are on time.
- Take a leadership role to obtain and share best practices with internal partners. Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.
- Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
- Identify and participate in process, system, and tool improvement initiatives. Lead others in implementing process, system, and tool improvement initiatives.
Requirements
- Bachelor's degree (e.g., BS, BA) or equivalent professional experience in Clinical Data Management, Health, or Computer Sciences
- Advanced degrees preferred (e.g., Master, PhD)
- Approximately 4 years of experience in Pharmaceutical, CRO or Biotech industry or related field
- Experience in clinical drug development within the pharmaceutical or related industry
- Experience working with cross-functional stakeholders and teams
- Strong written and verbal communications skills (in English)
- Team leadership experience
- Strong 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
- Knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.)
- In-depth knowledge of project management and techniques and knowledge of team management principles
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- long-term incentive program
- vacation - up to 120 hours per calendar year
- sick time - up to 40 hours per calendar year; up to 56 hours for employees in Washington State
- holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
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