Analyst II Central Monitoring Manager

Job Description:

Location- Mumbai/ Hyderabad/ Bangalore

Analyst II Central Monitoring Manager

Position Summary:

The Analyst II Central Monitoring Expert is an individual contributor with knowledge of central monitoring and Analytical Risk Based Monitoring (ARBM) practices, data analytics, methods, processes, and technologies that supports the execution of ARBM activities for clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures.

The Analyst II Central Monitoring Expert supports central monitoring processes and ARBM activities for multiple clinical trials and may work in combination with other Central Monitoring Experts.

The Analyst II Central Monitoring Expert may provide input into central monitoring and ARBM-related recommendations and decisions for specific trials or assignments that can have an impact on study processes and oversight of study participant safety and data quality. This position receives ongoing direction from their functional manager, Central Monitoring Leader, and/or other Central Monitoring Experts to achieve objectives.

Principal Responsibilities:

Executes central monitoring activities for clinical trials within assigned scope of responsibility in line with portfolio timelines and priorities, including support of set-up, execution and close-out as outlined in the end-to-end process.

Contributes to the ongoing development of the clinical trial ARBM model and related processes.

Conducts activities in compliance with J&J and Central Monitoring SOPs, processes and policies.

Facilitates smooth and effective communication, managing multiple communication streams. Follows agreed escalation pathways where needed.

May support innovation or process improvement projects which may include but are not limited to requirements development, user acceptance testing and identification of improvements to existing and new analytical tools.

This position may be specialized into the following roles based on business needs: Central Monitoring Manager, Central Monitoring Reporting Expert

Central Monitoring Manager role-specific responsibilities:

Supports trial central motoring activities including set-up, execution and close-out as outlined in the end-to-end process.

Supports the cross-functional study team in the completion of ARBM related study start-up processes, such as protocol assessment, protocol de-risking, integrated risk management plan.

Supports identification of Critical to Quality (CtQ) factors and the translation of CtQ factors into easily interpretable reports in collaboration with Statisticians & Programmers.

Uses various systems and databases to analyse risks related to trial quality/performance and compliance and identify trends and early warning signals.

Participates in the cross-functional Central Monitoring Working Group (CMWG), reporting out potential risks.

Supports execution of ARBM strategies by study team members, reviewing actions taken by the central or local team members to investigate, resolve, and document potential risks and resolutions.

May support or contribute to the activities relating to the development and oversight of Study-Specific Reports (SSRs), analysis of Central Statistical Surveillance (CSS) and support to enhancements of existing analytical tools.

Central Monitoring Reporting Expert role-specific responsibilities:

Executes activities relating to the development and oversight of study specific reporting needs, analysis of Central Statistical Surveillance (CSS) and enhancements of existing analytical tools.

Responsible for delivery of study-specific configuration activities including reporting specifications, platform configuration, implementation, and maintenance.

In collaboration with Functional Leadership supports strategies to utilize appropriate sourcing and operating model for assigned trials.

Principal Relationships:

Functional contacts within IDAR include but are not limited to Functional Leadership, Data Management Leaders, Global and Clinical Data Managers, Data Acquisition Experts, Clinical and Statistical Programmers and Regulatory Medical Writers.

Functional contacts in J&J Innovative Medicine include but are not limited to Clinical Teams, Trial Delivery Leaders, Trial Delivery Managers, Local Trial Managers, Site Managers, Clinical Risk Managers, and Biostatisticians.

External contacts include but are not limited to External Service Providers.

Education and Experience Requirements:

Bachelors degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Health Sciences or Data Sciences. Advanced degrees preferred (e.g., Masters, PhD).

Experience in Pharmaceutical, CRO or Biotech industry or related field or industry.

Working knowledge of Central Monitoring and Risk-based Quality Management (RBQM)/Risk-Based Monitoring (RBM) concepts.

Working knowledge of regulatory guidelines (e.g., ICH-GCP).

Demonstrated understanding of data analysis and familiarity with basic statistical concepts.

Experience supporting project and risk management, helping to lead teams to successful outcomes.

Experience working with technology platforms and systems used for the collection, analysis and reporting of data.

Ability to effectively collaborate in an environment of cross-functional stakeholders, plan and coordinate tasks effectively.

Strong ability to communicate effectively (written and verbal).

Good written and verbal communications skills (in English).

Knowledge of clinical drug development processes.

Required Skills:

Preferred Skills: