Central Monitor (India)
About The Position
As part of the Clinical Monitoring group, the Contract Central Monitor has the overall responsibility timely and high-quality risk-based monitoring analytics supporting the Innovaderm portfolio of clinical trial projects.
This role will be perfect for you if:
- You enjoy working for a mid-sized CRO where your contributions are noticed and valued
- You enjoy implement global strategies and initiatives
- Implement global strategies, initiatives, processes, and standards (SOPs) to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
- Provide technical expertise to set up and test study level Risk-based Monitoring system
- Review study level system outputs to process for the signal and action management
- Ensure central monitoring/RBM system alignment with the protocol and adherence to ICH GCP, SOPs, corporate standards and regulatory requirements.
During study planning and start up:
- Support the study management team by contributing to the identification of protocol critical data and processes
- Support the study management team by contributing to the protocol and site risk assessment
- Support the study management team by contributing to the data and clinical monitoring plans
- Support the study management team by contributing to the identification of key risk indicators (KRIs) and other detection methods
- Preparation and review of the study central monitoring plan
During study conduct:
- Perform periodic reviews of aggregate clinical trial and central monitoring data, as described in the central monitoring plan, to include, but not limited to, data listings, key risk indicators to identify “at risk” site behaviors and trends to further support the clinical monitoring team and direct monitoring activities.
- Meet with project managers and site monitors to discuss the “at risk” site behavior and provide guidance for additional site interventions, remote and on-site monitoring activities.
- Review the effectiveness of the recommended actions and take appropriate additional actions if desired effect is not observed.
- Provide periodic risk profile reports, as described in the central monitoring plan, to the site and remote monitors, for all investigational sites.
- Conduct root cause analysis on the risk signals, using available data (e.g. listings, remote monitoring of eCRFs, trip reports, KRI source data).
- Conduct periodic review, as per the central monitoring plan, of aggregate data for trend across sites within a country, across sites within a study, sites across studies to contribute to the continuous risk assessment process
- Notify the study management team if any new risks are emerging
- Support study management team in risk review and management activities
- B.Sc. in a related field to clinical research and at least 6 yrs experience in clinical trial research.
- A minimum of 2 yrs experience in two or more operational areas; such as, clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management.
- Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
- Experience managing multinational, multicenter trials in Phase II & Phase III setting
Knowledge and skills
- Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations;
- Ability to work autonomously
- Ability to organize tasks, time and priorities; ability to multi-task
- Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally
- Excellent interpersonal skills
- Strong problem-solving abilities
- Strong ability to carry out different projects and work under pressure while meeting timelines.
- Knowledge of clinical trial database systems (EDC, IRT, CTMS etc)
- Mastery of Microsoft Office suite, specifically MS Excel
- Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
At Innovaderm, you will work with brilliant and driven professionals. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
As a Contract Central Monitor, you will be eligible for the following conditions:
- Flexible work schedule
Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Canada, Innovaderm continues to grow and expand in North America and Europe.