Hobson Prior are seeking a Study Lead Monitor to join a pioneering organisation who focus on delivering innovative products and solutions to enhance human, animal and plant health. The Study Lead Monitor is responsible for representing and overseeing all aspects of the monitoring and site management activities for the assigned less complex Phase II – IV clinical trials for Global Clinical Development and Global Medical Affairs.
- Accountable for overseeing all operational aspects of monitoring and site management activities for the assigned 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.
- Overseeing the operational conduct and quality oversight of the study from the country perspective.
- Reviews Country Monthly Reports, tracks operational study activities and progress, proactively identifies issues and escalates appropriately.
- Recognises potential study specific resource constraints and liaises with LHMSM for LHMSM to resource study appropriately.
- Co-operates with GCO-Business Management & Operational Oversight-GCO to develop Monitoring and Site Management component of the Operational Quality Oversight Plan and if required, Data Verification Initiatives.
- Conducts co-monitoring visits and reviews Periodic Monitoring Visit Reports according to the Operational Quality Oversight Plan.
- Accountable for developing the study specific Monitor Training Plan and Investigator Site Training Plan.
- Accountable for developing Monitor training materials, ensure study specific training of Monitors, trains new Monitors to the study and reviews and approves training content changes.
- Develops Investigator and Site staff training material for functional and operational study activities. Makes presentations as assigned at Investigator Site and/or Monitor Training as assigned.
- Accountable for developing the Study Monitoring Plan and determining Investigator delegation responsibilities for the study and obtains requisite functional approvals.
- Develops training material and training plan to ensure all Monitors assigned to the study have a thorough understanding of the Monitoring Plan and study expectations.
- Strong written and verbal English communication skills.
- Strong oral presentation, interpersonal, problem solving, decision making, issue identification and issue resolution skills.
- Effective planning and organizational skills with a great attention to detail.
- Must have a bachelor’s degree or equivalent with 7 years of relevant healthcare experience with 5 years of direct monitoring experience in the pharmaceutical industry.
- In-depth knowledge of Good Clinical Practices and ICH-GCP (International Conference of Harmonization – Harmonized Tripartite Guidelines) and federal and international regulations.
- Awareness and understanding of cultural differences as well as regional operational differences.
- 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.