Senior Global Study Manager
An established biotechnology company is advertising a vacancy for three Senior Global Study Managers to join their London office. This organisation is acknowledged for their life-transforming medicines that help people with serious diseases. If you're looking for a change in career whilst changing the face of medicine, then this is the role for you.
- Provides operational input into protocol development
- Provides input into baseline timeline development and management
- Leads risk assessment and identifies risk mitigation strategies at the study level
- Monitors progress for site activation and monitoring visits and acts on any deviations from plan
- Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
- Monitors data entry and query resolution and acts on any deviations from agreed metrics
- Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues
- Oversees the execution of the clinical study against planned timelines, deliverables and budget
- Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
- Assigns tasks to Clinical Study Management staff and supports their deliverables
Skills and Requirements
- Bachelor's degree and minimum of 6 years relevant industry experience; advanced degrees may be considered in lieu of relevant experience.
- Demonstrated interpersonal & leadership skills
- Ability to understand and implement the strategic direction and guidance for respective clinical studies
- Ability to build productive teams and collaborations
- Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
- Experience in global clinical trial operations including experience developing protocols and key study documents
- Effective project management skills, cross-functional team leadership and organizational skills
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 contact Jack O'Neill at 0203 846 0646 or upload your CV on our website - www.proclinical.com/send-cv
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.