Central Operations Monitoring Manager-(1700007I)
Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for Central Operations Monitoring Manager.
As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.
Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.
The focus of the Central Operations Monitoring Manager (COMM) is to manage
the development and implementation of the Risk-Based Monitoring (RBM) activities from an operational perspective.
The role executes the central operations clinical trial monitoring activities across the various phases of trial execution.
The range of tasks includes activities such as providing input into the integrated RBM plan, monitoring guidelines, and Source Data Verification (SDV) plan, ensuring historical clinical trial site performance is gathered, performing trend analysis, maintaining oversight on clinical trial site risk parameters and ensuring appropriate actions are taken by the Global Clinical Project Management (GCPM) and Global Clinical Monitoring (GCM) Functions to investigate the potential risks, monitor operational risk parameters at a clinical trial level and lead lessons learned activities related to Central Monitoring.
* Contribute to the development of the initial and periodic risk assessments using a risk assessment tool
* Critically review and provide input in the Quality Risk Management Plan (QRMP) in collaboration with the Clinical Trial Team (CTT)
* Provide input into development of functional plans to ensure alignment with the QRMP
* Work with functional leads to develop/recommend reports for data display for risk identification and management
* Review data and standard reports at regular frequency to identify trends, inconsistencies, critical issues and unusual patterns of data that may be indicative of issues requiring follow up or escalation
* Provide input into the development of the monitoring guidelines
* In conjunction with the project team, provide input into developing thresholds that are indicative of performance issues and increased clinical trial and clinical trial site risk
* Perform and document Centralized Monitoring activities as outlined in the monitoring guidelines and quality risk plan and escalate issues
* Provide input into the development of data analysis report templates
* Issue periodic status reports on Centralized Monitoring activities as defined in the Centralized Operations Monitoring Plan
* Present status of Centralized Monitoring activities (e.g., identified risks, mitigation strategies, trends) at project team meetings and communicate issues
* Confirm appropriate data and associated reports are being received as outlined in the Centralized Operations Monitoring Plan
* Develop and implement new or revised Centralized Monitoring procedures and guidelines
* Work with team members (e.g., Statistics, Clinical, Medical Monitor) to develop/recommend reports for ongoing improvement and displaying clinical data indicative of project/clinical trial/clinical trial site performance
* Coordinate and/or manage junior members of a Centralized Monitoring Team
* Support training of newly assigned employees on project-related Centralized Monitoring procedures related to risk based activities
* Identify critical data and processes associated with the clinical trial execution, identify analytics for use in Centralized Monitoring, conduct review of clinical and operational data analytics, lead the identification of issues, and drive issues to resolution
* Bachelor of Science (BS) degree is required; Master's Degree or equivalent is preferred
* A minimum of 10 or more years of clinical trials experience required (i.e., clinical operations, data management, statistics, or other relevant clinical development experience) in the pharmaceutical industry or Contract Research Organization (CRO)
* Profound knowledge of International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and overall drug development processes
* Good understanding of Actelion's clinical operations model including the roles and responsibilities of the different stakeholders is essential
* Ability to operate and proactively use various systems and databases (Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems
* Good data analysis and technical skills in the area of clinical trials/clinical data and the ability to identify risks and trends is required
* Ability to work with a set of predefined common risk and ability to adapt to protocol specific risks
* Excellent problem-solving skills
* Proven track record of effective teamwork and ability to work in a cross-functional team environment
* Advanced effective communication skills and stakeholder management
If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.
:Sep 11, 2017