J&J Life Sciences Job Opening – Apply Online For Manager Vacancy
Senior Specialist Central Monitoring Manager Job – Mumbai/Bangalore/ Hyderabad
Job Title: Senior Specialist Central Monitoring Manager – Mumbai/Bangalore/Hyderabad
Function: R&D
Sub Function: Clinical Trial Administration
Location: Greater Mumbai, Maharashtra, India
Date Posted: Dec 19 2023
Requisition Number: 2306158269W
Description
Integrated Data Analytics and Reporting (IDAR)
Position Title*: SENIOR SPECIALIST CENTRAL MONITORING MANAGER
(*Title may vary based on Region or Country requirements)
Position Summary: The Senior Specialist executes and manages the Analytical Risk-Based Monitoring (ARBM) processes and day-to-day activities for up to five trials of medium complexity and three trials of high complexity or a combination of high and medium complexity trials in conformance to all relevant laws, regulations, guidelines, policies and procedures.
Principal Responsibilities
- Oversees, executes, and/or manages Risk Management Central Monitoring (RM-CM) department activities for all phases of ARBM including set-up, execution and close-out as outlined in the end to end process.
- Lead the cross-functional study team in the completion of ARBM-related study start-up processes, such as the protocol assessment, protocol de-risking, iARBM plan creation, ARBM-related input into the monitoring guidelines and the creation of tSDx specifications with a high degree of influence on translating ARBM concepts.
- Analyzes data from available reporting mechanisms and dashboards and concisely organizes potential risks for reporting out at the Central Monitoring Working Group (CMWG). Identifies CtQ items that require the development of study specific reports and in turn works with statisticians & programmers to translate those CtQs into easily interpretable reports.
- Exhibit high degree of leadership skills to support ARBM strategies and leads the cross-functional CMWG.
- Analyzes and identifies risks requiring further review and follow up as part of routine CMM work and CMWG conduct and ensures appropriate actions are taken by the central/local teams members (e.g. GCO, Portfolio Delivery, IDAR) to investigate, resolve and document potential risks identified via CMM data review, including ensuring adequate documentation of resolution.
- Provides input into lessons learned activities related to ARBM.
- Contributes to the ongoing development of the ARBM model of clinical trial management and related processes.
- May support activities driven by the RM-CM Capability Center. These would include development and oversight of Study-specific reports, analysis of Central Statistical Surveillance and support to enhancements of existing analytical tools. As needed, support Innovation Projects which may include but are not limited to participation in requirements development, user acceptance testing and identification of improvements to existing and new analytical tools.
- Perform other work-related duties as assigned.
Key Skills (Learning, Applying & Leading)
- Clinical trials experience in the pharmaceutical/medical device industry or CRO.
- Knowledge of ICH-GCP, risk identification, management and analysis and overall drug development processes.
- Ability to operate and proactively use various systems and databases to analyze risk related to trial quality/performance and compliance and identify trends and early warning signals.
- Data analysis and technical skills in the area of clinical trials/clinical data.
- Strong ability to effectively communicate and understand issue escalation.
- Advanced leadership skills allowing smooth and effective communication, including the ability to manage multiple communication streams and exert influence on ARBM concepts with key stakeholders within the cross-functional study team.
Principal Relationships
Internal: Functional Manager, CMMs, BRQC, GTLs, CTMs, GPLs, Senior Leadership, R&D study team (e.g., SRP), protocol owners, other IDAR colleagues, and Medical Affairs (as applicable)
External: Vendor representatives (as applicable)
Qualifications
Education and Experience Requirements:
- Minimum: B.S. degree required. Three or more years of relevant work; however, other relevant experiences and skills may be considered. Knowledge of basic statistical concepts and data science principles.
- Preferred: Master’s Degree in Life Sciences. Understanding of the Janssen R&D clinical operations model. Understanding of clinical research operations including on-site monitoring and site management.
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