The Manager Analytical Monitoring Leader is an experienced individual with an in depth understanding of Site Monitoring or Central Monitoring or Data Management, and Analytical Risk Based Monitoring (ARBM) practices, data analytics, methods, processes, and technologies
In this role the Manager Analytical Monitoring Leader directly contributes to delivery of the J&J Research & Development through effective leadership and accountability for Analytical Monitoring delivery on clinical development programs and/or strategic innovation programs and projects
This position reports to Analytical Monitoring Functional Leadership and represents Analytical Monitoring in cross functional discussions, influencing key stakeholders and driving strategic discussions and decisions
This position plays an important role in the growth and development of the group and contributes to organizational effectiveness, transparency, communication, innovation, capability growth, recruitment, onboarding, performance management, and development of people while building an inclusive working environment
In addition, the Manager Analytical Monitoring Leader plays a role in change leadership and driving the enhancement of functional, technical and/or scientific capabilities, processes, and tools within the function
This position develops strong and productive working relationships with key stakeholders in GCO (Global Clinical Operations), within IDAR and Global Development, in addition to broader partners and external suppliers
Principal Responsibilities:
Drive the strategy and planning, execution, and completion of all analytical monitoring activities and deliverables within assigned scope ensuring quality, compliance to J&J and industry standards, consistency, and efficiency
Accountable for Analytical Monitoring delivery within region/ assigned area/program
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
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 external partners on Analytical Monitoring related deliverables
Ensure staff compliance with department SOPs, policies, and regulatory guidance documents
Contribute to the development and maintenance of departmental policies, procedures, training, and standards
Contribute to the development of functional vendor contracts and oversee of delivery in line with agreed milestones and scope of work, R&D business planning and budget estimates
Contribute to the enhancement of functional, technical and/or scientific capabilities, processes, and tools within Analytical Monitoring
Foster a culture of continuous improvement within the team
Contribute to 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 Analytical Monitoring Processes or Systems
Provide people leadership with responsibility for hiring, attracting, and retaining top talent, performance management, career development and HR administration for direct reports
Shape & maintain robust relationships within local & broader GCO team, within IDAR and serve as the Analytical Monitoring primary point of contact to regional/ TA/ program level cross functional stakeholders
In collaboration with Functional Leadership, define, execute or support the Analytical Monitoring strategy in alignment with IDAR, GCO, GD and JJIM R&D strategies to position the local and global team for success
Take a leadership role for Analytical Monitoring related aspects of regulatory agency inspections and internal audits
Coordinate real time inspection readiness for all Analytical Monitoring deliverables Contribute to CAPA and issue resolution in accordance with required timelines
Review operational and quality metrics regularly and drive follow-up actions as appropriate
This is not an exhaustive, comprehensive listing of job functions
May perform other duties as assigned
Principal Relationships:
Reports into people manager position within functional area eg Regional Analytical Monitoring Head
Functional contacts within GCO include but not limited to Site Managers (SM), Local Trial Managers (LTM), Manager Clinical Operations (MCOs), Country Heads, Other Leaders and/ or leads in GCO
Functional contacts within IDAR include but not limited to: Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, and system support organizations
Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but not limited to: Global Program Leaders (GPLs), Trial Delivery Leaders (TDLs), Trial Delivery Managers (TDMs), 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
Bachelors degree (eg, BS, BA) or equivalent and professional experience preferably in Clinical Data Management, Central Monitoring, Site Monitoring, Health or Computer Sciences
Advanced degrees preferred (eg, Master, PhD)
Approx
6+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry with experience in people management skills including staff performance management and people development
Robust knowledge of data management, site monitoring or central monitoring practices (including tools and processes)
In-depth knowledge of regulatory guidelines (eg, ICH-GCP) and other regulations
Established record of project, risk, and team management and leading teams to successful outcomes
Proven track record in planning and coordinating strategy and delivery including managing multiple priorities
Experience 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
Track record of applying flexible mindset and ability to work in a fast-changing environment with limited supervision
Excellent written and verbal communications skills (in English)
Preferred
Proven record of innovative thinking to allow for optimal design and execution of clinical development strategies
Track record of development and implementation of a business change/innovative way of working and strong influencing skills
Experience working with clinical and operational data from various sources
