Ref #: 28504

Employment type: Permanent - Full-Time

Location: Poland

Posted: 16-Apr-2021

Description

Overview:
Central Monitoring &Risk Management Specialist’s (CMRMS) responsibilities include working within the Risk Management-Central Monitoring Group and leads clinical study teams in the study-specific design and implementation of Analytical Risk-Based Monitoring (ARBM) on clinical trials (Ph I-IV). Responsible for risk identification & mitigation, data analysis, leading cross-functional teams, communicating with study team members on multiple levels, providing ongoing training on ARBM-related processes to teams.

Responsibilities:
• Lead central study teams (including trial managers, data managers, study physicians, study scientists, quality colleagues, and statisticians) in the identification of critical study data/processes and in related potential risks.
• Coordinate trial team translation of identified risks and critical data/processes into risk mitigation and oversight plans to be followed during study execution.
• Lead the central study team in making appropriate decisions regarding site management, data review, and contingency plans and provide their own input into related study plans.
• Coordinate with the cross-functional central study team to ensure compliance with the risk oversight plan established during ARBM design and to oversee site risk parameters.
• Responsible for ongoing study and operational data reviews, as well as associated follow-up to resolution of their findings in conjunction with appropriate central and field team members. This is to be accomplished through the utilization of multiple internal systems, internal/external databases, custom report creation, and the use of a selection of data analysis and visualization tools, followed by the proper interpretation and investigation of risk indicators and trends.
• Successfully lead recurring cross-functional study team meetings inn a virtual environment. Organize, lead, document meetings, communicate effectively, and guide and influence colleagues in new methodologies is critical.
• Supporting capacity to a Primary Central Monitoring Manager

Requirements:
• BS degree, Master’s Degree or Equivalent.
• 3 or more years of Clinical trials experience required (i.e. clinical operations, data management, statistics, or other relevant clinical development experience) in the pharmaceutical/medical device industry.
• Possession of a strong analytical capability and mindset.
• Knowledge of ICH-GCP and overall drug development processes.
• Ability to operate and proactively use various systems and databases (CTMS, Rave, KPI Dashboard, Spotfire, etc.) to analyze trial quality/performance and compliance and identify trends and potential signals.
• Data analysis and technical skills in clinical trials/clinical data.
• Ability to successfully work with global and remotely based teams.
• Proficient in speaking and writing in English. provided. Good written and oral communication skills as appropriate.

How to apply?
This is an exceptional opportunity within a global organisation who offers rewarding careers. If you want to be a part of this exciting opportunity who offers a competitive salary, excellent benefits package, please contact Dariusz Sternlicht, Recruitment Consultant at DOCS and email your up-to-date CV to: dariusz.sternlicht@docsglobal.com

Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.

It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.

At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.