Manager, Analytical Monitoring Leader

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Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

People Leader

All Job Posting Locations:

Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, India

Job Description:

Integrated Data Analytics and Reporting (IDAR)

Manager Analytical Monitoring Leader

Position Summary:

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 e.g. 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

• Bachelor's degree (e.g., BS, BA) or equivalent and professional experience preferably in Clinical Data Management, Central Monitoring, Site Monitoring, Health or Computer Sciences. Advanced degrees preferred (e.g., 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 (e.g., 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

Other:

• Approx.

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