Hobson Prior are looking for a Global Study Manager 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 position will be responsible for all aspects of assigned Phase II-IV global and local clinical trials within the approved Clinical Development Plan.

Job Responsibilities:

• Manages and is responsible for all activities related to global and local clinical trials from the approved Study Concept to the Clinical Study Report.
• Develops the comprehensive overview and operational plans for the study.
• Manages operational study feasibility conducted by country organisation to determine study feasibility and final country selection. Based on the feasibility summary, develops study timelines, milestones, outsourcing plan and proposed external study budget.
• Responsible for the development of the Core Study Documents and processes including: Data Collection tool (Remote Data Entry/Case Report Form), Study Monitoring Plan, Drug Forecasting and Clinical Study Report.
• Accountable for Study Protocol and ensuring adequate Investigator selection in each country to meet study enrolment and timelines.
• Accountable for developing the total external study budget and accountable for providing monthly and yearly estimates.
• Responsible for tracking study budget, initiating payments, providing monthly information to Controlling and GCL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues.
• Recognises, implements, leads and manages a cross-functional Study Team for the duration of the study, working with functional line management to identify team members and resolve issues.
• Disseminates relevant information to team members in effective and timely manner. Represents the Study Team as a member of the Global Clinical Project Team.
• Manages, tracks, and responsible for ensuring ongoing study activities, study execution and timelines are met.
• Tracks and compiles patient enrolment, data cleaning progress and overall study progress.

Key Skills:

• Effective written and verbal communication, thorough knowledge of oral and written English, strong oral presentation, excellent interpersonal, decision-making and issue resolution skills are required.
• In addition, the incumbent requires effective planning and organisation skills, attention to detail and excellent follow through.

Requirements:

• Bachelor's degree or equivalent education with extensive healthcare experience
• At least some experience of working within a clinical operations environment in the pharmaceutical industry or CRO.
• Experience of monitoring and/or clinical trial/study management experience preferred.
• In-depth knowledge of Good Clinical Practices (GCP), international regulations (International Harmonisation Committee-ICH regulations).
• Awareness and understanding of cultural differences as well as regional operational differences required.
• Comprehensive knowledge of the drug development process including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters.

Apply now:

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.