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Clinical Programming Lead
The Clinical Programming Lead is an experienced clinical trial programmer with expertise in industry standard and complex data structures, programming languages, and/or reporting solutions with proven technical capabilities in leading clinical trial activities and/or teams in accordance with departmental processes and procedures.
Netherlands, Switzerland, Italy, Germany, Spain, France, United Kingdom
Janssen Pharmaceutica N.V. (7555)
The position is responsible for providing expertise, planning, creation and oversight of one or more clinical programming trial activities of moderate to high complexity/criticality. Including data models for fit for purpose reporting consumption and/or CDISC submission ready SDTM tabulation packages (aCRF, define.xml, cSDRG, etc). Creates and executes edit check programs, cross and study specific reporting solutions to aid in monitoring of safety, risk, compliance and ensures quality data review.
Depending on departmental needs, this position may fulfil the role of a Portfolio Lead.
Responsible for creating efficiencies in the clinical data flow using metadata driven approaches and ensuring the highest level of consistency and quality across trials they support.
Additionally, they provide expertise in relevant technical areas and on process improvement, maintenance and innovation initiatives working proactively to connect with teams, peers and leadership within and cross functions, sharing and implementing lessons-learned and shaping processes and practices.
May perform reporting solutions role creating study specific reports translating clinical study team needs aggregating clinical data sources into custom data and reports to monitor safety, risk and compliance. The reporting solutions role contributes to the improvement of clinical safety, risk and compliance review and cleaning efficiency by providing innovative and forward-thinking reporting solutions, report library templates, macros and other solutions for use cross studies.
De functie / The role
• Accountable for one or more clinical programming trial activities of moderate to high complexity, scope and/or criticality.
• Performs comprehensive review of, and provides input into, project requirements and documentation. Identifies gaps, proposes solutions and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Provides technical and project specific guidance to team members to ensure high quality and on-time deliverables in compliance with departmental processes.
Ensures latest standards are being utilized, current technologies are deployed.
• Responsible for planning, coordination, oversight and execution of team activities as appropriate and provides technical and project specific guidance to team members to ensure quality and ontime deliverables in compliance with departmental processes and procedures.
• Create and/or review specifications for mapping internal data review model for fit for purpose reporting consumption and/or submission ready CDISC SDTM. Design mapping algorithms for nonstandard conversions.
• Responsible for creation or review of internal data model fit for purpose reporting consumption and/or submission ready CDISC SDTM packages for health authority submissions and keeping abreast in changing regulatory requirements. Program, or oversight of quality review checks, cross and study specific reports for use by team members and consumers of data.
• May perform role that oversees or programmatically aggregates clinical data sources into custom data model for fit for purpose consumption cross and study specific export solutions performing appropriate quality control and verification in support of assigned reporting activities.
• As applicable, oversees activities outsourced to vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality.
• Collaborates effectively with team and cross-functional counterparts and vendors to achieve project goals.
• Independently manages interfaces and escalations with cross-functional project teams.
• Support and/or lead in developing and implementing process, system and tool improvement initiatives within compliance with departmental processes and procedures.
• Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position.
• The position mentors and coaches and may delegate work. Responsibilities for others: Principal Relationships:
• Reports into people manager position within the functional area. Accountable to the Portfolio Lead, Clinical Programming and/or Associate Director, Portfolio Lead for assigned activities and responsibilities.
• Functional contacts within organization include but are not limited to; Data Management, Clinical Data Standards and Transparency, Process Sourcing & Compliance, Statistical Programming & Analysis, Risk Management Central Monitoring, IDAR Therapeutic Area Leaders.
• Functional contacts within Janssen (as collaborator or peer) include but are not limited to Global Trial Lead or equivalent, EBIS, Quantitative Sciences, Biostatisticians, Regulatory, Clinical, BRQCQP&S.
• External contacts include but are not limited to, external partners, CRO management and vendor liaisons, industry peers and working groups.
Het profiel / Your profile
Bachelor’s degree or higher and/or equivalent in computer science, data science/data engineering, mathematics or another relevant scientific field (or equivalent theoretical/technical depth).
• Approximately 6-8+ years of clinical programming/clinical data management experience with increasing responsibility, preferably in the pharmaceutical/clinical trial environment.
• In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required.
• Advanced CDISC SDTM knowledge. • Experience in planning and coordinating one or more team activities as necessary.
• Project management skills and knowledge of team management principles are required.
• Experience working with cross functional stakeholders and teams.
• Demonstrated written and verbal communications skills.
• Vendor management oversight experience.
• Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.