ProClinical is seeking a Study Lead Monitor for a multinational pharmaceutical company based in Helsinki, Finland. The Study Lead Monitor (SLM) is a core member of the Study Team who is responsible and accountable for representing and overseeing all aspects of the Monitoring and Site Management activities for the assigned Phase II - IV clinical trials for Global Clinical Development and Global Medical Affairs. These global clinical trials are conducted within the standards set by Internal Global Development, according to Good Clinical Practices (GCP) and applicable regulatory and legal requirements.
- The SLM works in close collaboration with the Study Manager and the Study Team for internally monitored as well as outsourced clinical trials.
- The SLM is the monitoring and site management expert on the core Study Team. This includes all operational aspects of conducting clinical trials from the Clinical Research Associates (CRA), Investigators and Site Staff perspective from study feasibility to study close out.
- The SLM is responsible for the training and quality oversight of monitoring and site management activities, oversees the operational activities of the study, and proactively identifies potential operational issues and works with the Country Lead Monitors to ensure proper actions are implemented to successfully conduct the studies. Specific activities relating to the training and quality oversight include: developing the Monitor & Site Training Plan, coordinating Study Investigator Meetings, contributing to the Monitoring Quality Oversight Plan, developing Data Verification Initiatives, reviews of Country Monthly Study Reports to identify any operational study related trends, and if applicable, is an active member on the Fraud & Misconduct Team. These activities are conducted in close collaboration with the Study Manager, Study Team and other functions within Global Clinical Operations (Operational Oversight, Business Management and Data Management).
- The SLM leads, manages, and motivates the geographically dispersed Global CRAs and CLMs assigned to a given trial and is responsible for ensuring continuous information flow and adequate documentation to and from the Study Manager and Study Team.
- The SLM is responsible for clinical trials which would typically include less than 15 countries.
Skills and Requirements:
- Bachelor's degree or equivalent with 7 years of relevant Healthcare experience with 5 years of direct monitoring experience in the Pharmaceutical Industry. As the expert of Monitoring and Site Management processes and activities on the Global Study Team, this position requires in-depth knowledge of Good Clinical Practices (GCP) and ICH-GCP and international regulations. This position also requires awareness and understanding of cultural differences as well as regional operational differences.
- The comprehensive knowledge of the drug development process including: Monitoring and Site Management processes; Regulatory and Drug Safety requirements; and Data Management processes. Effective written and verbal English communication skills, strong oral presentation, interpersonal, problem solving, decision making, issue identification and issue resolution skills are required. In addition, effective planning and organizational skills, attention to detail and excellent follow through are needed.
- Also, in-depth knowledge about oncology is required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Pontus Larsson on +44 203 3193 030 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.