About the role

Senior Data Manager overseeing clinical data management at Johnson & Johnson. Leading teams in developing innovative healthcare solutions and saving lives through advanced treatments.

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

Bachelor's degree (e.g., BS, BA) or equivalent professional experience required, preferably 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 or industry
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 as well as understanding of data privacy rules in relation to clinical data exchange
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