Hobson Prior is currently seeking a Study Lead Monitor to join a multinational pharmaceutical company on a contract basis. Our client focuses on delivering services and products that benefit and improve the quality of people’s lives. This key position is responsible for representing and overseeing all aspects of the monitoring and site management activities for the less complex Phase II – IV clinical trials for Global Clinical Development and Global Medical Affairs.
- Accountable for overseeing all the operational aspects of monitoring and site management activities for the less complex Phase II-IV internally monitored and outsourced clinical trials.
- Ensures study processes and expectations correspond to the practicality of conducting the trial from the operational perspective, from study feasibility to study close out.
- Manages the assigned Country Lead Monitors and CRAs globally and supports GMSM Country Management in overseeing the operational conduct and quality oversight of the study from the country perspective.
- Liaises with GCO- Business Management and Operational Oversight to develop monitoring and site management component of the Operation Quality Oversight plan.
- Responsible for developing the study specific Monitor Training Plan and Investigator Site Training Plan.
- Accountable for developing the Study Monitoring Plan and determining Investigator delegation responsibilities for the study and obtains requisite functional approvals.
- For outsourced trials, the SLM is the first point of contact with CLMs, LHMSMs and Country Medical Directors and makes sure applicable information is passed on efficiently and ensures required country review of applicable documentation.
- Leads and organises assigned Country Lead Monitors.
- Excellent interpersonal, written and verbal English communication skills.
- Robust oral presentation, problem solving, decision making, issue identification and issue resolution skills are required.
- Effective planning and organizational skills and a meticulous eye to detail.
- Bachelor’s degree or equivalent with a minimum of 7 years of relevant healthcare.
- Minimum of 5 years of direct monitoring experience in the pharmaceutical industry.
- In-depth knowledge of Good Clinical Practices and ICH-GCP and federal and international regulations.
- Understanding of cultural differences as well as regional operational differences is required.
- Knowledge of the drug development process including: monitoring and site management processes, regulatory and drug safety requirements and data management processes.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.