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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