Director, Data Acquisition and Coding - Clinical Data Mgmt.
- United States
Data Acquisition Head
The Data Acquisition Head within Integrated Data Analytics and Reporting (IDAR) is an experienced leader with strong project and people leadership skills accountable for data acquisition and coding deliveries for the entire portfolio across all therapeutic areas and development phases. In addition, this position is accountable for deploying new technical and process solutions per portfolio needs delivering increased productivity, quality, performance and innovation within the Data Management functional area.
Reporting into the Head of Data Management, this position uses in-depth understanding of the Data Management function in combination with expert technical data acquisition and coding capability as well as process knowledge, to co-design, co-develop and deploy innovative solutions to enable automation, efficiency and regulatory compliance.
Through effective collaboration and partnership with Data Management Leadership, other functions internal to IDAR such as Clinical Programming and Clinical Data Standards as well as GCO, PDO, QS/SDS, eBIS, QA and others, the Data Acquisition and Coding group evaluates stakeholder needs and provides strategic input to deliver innovative relevant solutions that are optimized and cost effective by leveraging cutting edge technologies and processes in alignment with overall DM, IDAR and GD strategies.
The Head of Data Acquisition and Coding will coordinate, oversee and contribute to projects designed to deliver and implement innovative technical solutions in support of the portfolio needs. As the coordinator of project leaders, the position applies strong team leadership, project management and strategic insights to lead complex technical innovation projects from a business perspective. In addition, this position supervises Data Management Innovation Leads, building strong technical capability within the Data Acquisition and Coding group.
• This position is accountable for the operational delivery of all data acquisition and coding aspects with quality and compliance and adherence to established standards for the entire Janssen portfolio across multiple therapeutic areas and all phases of development.
• This position supervises Data Acquisition Experts, Clinical Coding Experts and Data Management Innovation Leads and acts as the business owner of key data acquisition processes and/or clinical data coding processes
• Identifies process optimization and innovation across therapeutic areas within the data acquisition and coding group, such as technical eCRF build, trial level Data Transfer Agreement optimization, real time access to data, coding automation, business system support and ensures alignment of processes and procedures.
• Accountable for the strategy, design, development and deployment of DM innovation projects
• Coordinates all project leads and develops strategic intent communication for key stakeholders (deliverables associated with those projects, defining project strategy, developing roadmaps for innovation projects and support change management implementation)
• Maintains up to date knowledge of functional and departmental processes and bridges between technology and process to ensure optimal implementation to support the current and future needs of the business.
• Maintains knowledge of industry trends and technologies related to industry standard coding practices and methodology, novel data acquisition and cleaning approaches (eMR/eHR data acquisition, data transfer automation, implementation of data science opportunities AI/RPA/NLP), and applying knowledge to strengthen functional capability/efficiency.
• Connects and partners across technical groups within J&J to leverage institutional knowledge and solutions.
• Proactively engages in discussions with external vendor(s) in building innovative data acquisition solutions and complex systems working together with eBis and with the Data Management Process and Sourcing Head for deployment at portfolio level
• Acts as a functional area people leader and as a leader of leaders;
o Provides leadership to the Data Management department by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.
o Responsible for local administration and decision making associated with the management of assigned personnel, including recruitment/hiring, onboarding, performance management, budget, travel, etc.
o Ensures compliance of assigned teams and personnel with company and department SOP's, policies and regulatory guidance documents.
• Act as departmental sponsor/lead for organization initiatives and process improvement projects. Act as business owner for data acquisition and coding tools/systems or delegate as appropriate.
• Reports into the Head of Data Management
• Functional contacts within IDAR include but are not limited to Data Management Leadership team, SP&A Analytics Innovation Technical Lead, Data Collection Standards Head
• Functional contacts within Janssen (as collaborator or peer) include but are not limited to GCO, PDO, JCI, Quantitative Sciences, Biostatisticians, eBIS and cross-sector contacts.
• In collaboration with eBis, liaising with external partners including but not limited to: central and local laboratories, eCOA providers, digital data providers, eHR/eMR cplatform providers, DM CROs, eDC providers and vendor liaisons, industry counterparts and working groups.
Education and Experience Requirements:
•Master's degree or equivalent in data science/analytics, computer science, mathematics, or other relevant scientific field (or equivalent theoretical/technical depth) required. Advanced Degree (PhD or equivalent) preferred.
•Approximately 10+ years data management experience with increasing responsibility in a pharmaceutical/clinical trial environment preferred.
•In-depth knowledge of data acquisition, clinical coding and cleaning tools and processes
•5+ years of experience in a senior managerial position leading people is strongly preferred and a leader of leaders is preferred
•Demonstrated project leadership experience.
•Project management skills and experience.
•Strong problem-solving skills with an emphasis on product development.
•Excellent understanding of clinical development, quality and regulatory standards and policies relevant to data management (e.g. GCP, ICH)
•Excellent interpersonal and communication skills, able to naturally bridge scientific and businessparticipants; Track record in enabling effective international collaboration
•Proven track record in working across a matrix organization and demonstrates expert skills in building partnerships, negotiating agreements; excels at collaboration
•Outstanding verbal and written communications
Netherlands, Switzerland, United States, United Kingdom
Janssen Pharmaceutica N.V. (7555)
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