Lead Study Manager

Hobson Prior are looking for a Lead Study Manager to join a multinational pharmaceutical company on a permanent basis. Our client focuses on delivering services and products that benefit and improve the quality of people’s lives. This position will manage the planning, conduct, analysis and reporting of assigned global studies and complex local studies.

Job Responsibilities:

• Identifies, implements, leads and manages a global, cross-functional Study Team for the duration of the study, co-operating with functional line management to identify team members and resolve issues.
• Leads the operational planning and tracking of the site feasibility.
• Manages all study related activities from an approved study concept to the final Clinical Study Report to ensure study is conducted in high quality and within the given timeline and budget.
• Delivers operational input and insight into the preparation of the study protocol and contributes to other core study documents in close collaboration with the study team
• Measures study performance using appropriate systems, tools and techniques
• Leads study risk levelling and risk mitigation strategies
• Responsible for developing and tracking the total external study budget and accountable for providing monthly, quarterly and yearly estimates information to the Clinical Team and to Controlling.
• Represent as the Outsourcing Person in outsourced studies and manages the selection and oversight of external suppliers.
• Make sure all relevant IT-systems are updated with current and accurate information.

Key Skills:

• Ability to successful achieve results within a multi-cultural and geographically diverse team.
• Capable of creating team culture and promote team spirit.
• Effective communication skills both written and verbal.
• Excellent decision making and issue resolution skills.

Requirements:

• Bachelors degree or equivalent education.
• 8+ years of relevant healthcare experience, including 5 years Clinical Operations in the Pharmaceutical industry (this includes direct monitoring and clinical trial/study management experience).
• In-depth knowledge of Good Clinical Practices, federal regulations and international regulations.
• Has a proven track-record leading the initiation and completion of clinical studies.
• 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.