Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Data Analytics & Computational SciencesJob Sub Function:
Clinical Data ManagementJob Category:
People LeaderAll Job Posting Locations:
Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, IndiaJob Description:
Integrated Data Analytics and Reporting (IDAR)
Senior Manager Clinical Data Acquisition Leader
(*Title may vary based on Region or Country requirements)
Position Summary:
The Senior Manager Clinical Data Acquisition Leader is a highly experienced individual with an expert understanding of data management and/or acquisition strategies, practices, methods, processes, and technologies. In this role the Senior Manager Clinical Data Acquisition Leader directly contributes to delivery of the J&J R&D portfolio through effective leadership and accountability for Data Management delivery on large or complex clinical development and/or strategic innovation programs and projects.
This position reports to Data Management and Central Monitoring Functional Leadership and represents Data Management in cross functional discussions, influencing key stakeholders and driving strategic discussions and decisions with a high level of independence.
This position plays a critical role in the growth and development of the group and contributes to organizational effectiveness, transparency, and communication as a matrix leader driving projects, innovation, and capability growth and/or as a People Manager, through the recruitment, onboarding, performance management, and development of people while building an inclusive and diverse working environment.
In addition, the Senior Manager Clinical Data Acquisition Leader plays a critical role in change leadership and driving the enhancement of functional, technical and/or scientific capabilities, processes, and tools within the function.
Principal Responsibilities:
• Drive the strategy and planning, execution, and completion of all data management activities and deliverables within assigned scope ensuring quality, compliance standards, consistency, and efficiency.
• Proactively evaluate and manage resource demand, allocation, utilization, and delivery to meet current and future business needs. Ensure timely and effective maintenance of functional planning systems.
• Independently and effectively manage issue escalations, adopting appropriate escalation pathways.
• Anticipation, early detection, prevention and management of risks and issues impacting departmental deliverables and activities.
• Collaborate with internal cross-functional colleagues and external partners to define the data integration strategy for assigned programs/projects.
• Collaborate with external partners on data management related deliverables including co-development programs.
• Ensure staff/team compliance with department SOPs, policies, and regulatory guidance documents.
• Lead or contribute to the development and maintenance of departmental policies, procedures, training, and standards.
• Contribute to the development of functional vendor contracts and oversee delivery in line with agreed milestones and scope of work, R&D business planning and budget estimates.
• Drive the enhancement of functional, technical and/or scientific capabilities within data management.
• Influence the external industry and/or regulatory environment through active engagement in industry forums and working groups.
• May serve as a business process or system owner for Data Management Processes or Systems.
• May provide people leadership with responsibility for hiring, attracting, and retaining top talent, performance management, career development and HR administration for direct reports. May also take responsibilities of second level line management (i.e. leader of leaders).
This position may be specialized into the following roles based on business needs: Data Acquisition Leader
Data Acquisition Leader role-specific responsibilities:
• Accountable for Clinical Data Acquisition delivery within assigned area and scope including setup and management of data collection tools and/or acquisition of external data streams including but not limited to EDC, EHR, ePRO, eSource, EHR, Real World data and traditional and novel clinical data streams.
• Serve as the Clinical Data Acquisition primary point of contact for assigned area and scope.
• In collaboration with Functional Leadership, define the data acquisition strategy and sourcing/operating model for assigned programs.
• Support data acquisition related aspects of regulatory agency inspections and internal audits. Coordinate real time inspection readiness for all data acquisition deliverables.
• If people leader, typically provides people management for Data Acquisition Experts within assigned area and scope. May manage Data Acquisition Leaders.
Principal Relationships:
• Reports into people manager position within functional area (e.g., Director Data Acquisition).
• Functional contacts within IDAR include but not limited to: Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations.
• Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but not limited to: Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources and Project Coordinators.
• External contacts include but not limited to: External partners and suppliers, CRO management and vendor liaisons, industry peers and working groups.
Education and Experience Requirements:
Required
• Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health or Computer Sciences. Advanced degrees preferred (e.g., Master, PhD).
• Approx. 8+ years of (clinical data acquisition) experience in Pharmaceutical, CRO or Biotech industry or related field or industry. People management experience is mandatory.
• In-depth knowledge of data management practices (including tools and processes).
• In-depth knowledge of regulatory guidelines (e.g., ICH-GCP).
• Project, risk, and team management and an established track record leading teams to successful outcomes.
• Excellent planning and coordinating of Data Acquisition strategy and delivery.
• Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors.
• Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments.
• Excellent written and verbal communications skills (in English).
Preferred
• If Principal Responsibilities include people leadership; excellent people management skills including staff performance management and people development.
• Innovative thinking to allow for optimal design and execution of clinical development strategies.
• Development and implementation of a business change/innovative way of working.
• Experience working with data from eDC systems, eDC integration tools, and general data capture platforms.
Other:
• Approx. <10% travel (domestic or international) may be required.
Required Skills:
Preferred Skills:
Advanced Analytics, Clinical Data Management, Clinical Trials Operations, Data Privacy Standards, Data Savvy, Developing Others, Good Clinical Practice (GCP), Inclusive Leadership, Innovation, Leadership, Leverages Information, Regulatory Affairs Management, Research Ethics, Systems Development, Team Management, Vendor Management