Data Science Manager overseeing Data Science and ML Engineers at Wayflyer. Leading ML lifecycle from data preparation to deployment while collaborating with cross - functional teams.
About the role
- Analyst II Data Manager leading clinical data management for trials at Johnson & Johnson. Part of Innovative Medicine focusing on developing lifesaving treatments.
Responsibilities
- Take a leadership role with external suppliers, trial customers and other internal/external partners
- Analyze and provide input into decisions with direction from manager or Data Management Leader (DML)
- Gather and/or review content and integration requirements for eCRF and other data collection tools
- Establish conventions and quality expectations for clinical data
- Set timelines and follow-up regularly to monitor delivery of all data management milestones
- Review clinical data management documents ensuring appropriate quality
- Ensure compliance with regulatory guidelines and the documentation matrix
- Ensure real-time inspection readiness of all DM deliverables for the trial
- Create key functional plans 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
- Perform trial level oversight controls and/or execute data management activities with DML direction
Requirements
- Minimum of Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required
- Minimum of 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)
- Team leadership experience (preferred)
- Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols (preferred)
- In-depth knowledge of current clinical drug development processes (preferred)
- In-depth knowledge of applicable international guidelines regarding data management of clinical trials (preferred)
- Knowledge of technology platforms and systems to capture and process data (preferred)
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))
- vacation – 120 hours per calendar year
- sick time - 40 hours per calendar year
- 13 days holiday pay including Floating Holidays
- up to 40 hours work, personal and family time per calendar year
- parental leave – 480 hours within one year of the birth/adoption/foster care of a child
- bereavement leave – 240 hours for an immediate family member
- caregiver leave – 80 hours in a 52-week rolling period
- volunteer leave – 32 hours per calendar year
- military spouse time-off – 80 hours per calendar year
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