Clinical Study Manager
Are you a skilled project manager with experience in the pharmaceutical industry? Are you ready to take on complex projects and lead teams to achieve objectives? We are seeking a Clinical Study Manager to join a medical team and manage clinical studies.
As a Study Manager, you will be responsible for leading complex projects across the division, communicating timelines, and ensuring that clinical studies stay within time, budget and scope. Your ability to develop and manage plans will facilitate the achievement of objectives, and you will be able to anticipate and troubleshoot roadblocks, influencing teams to achieve targets for the division.
- Develop ideas, (co)-lead complex projects across business units and develop plans to achieve objectives.
- Approve the Study Startup, Study Monitoring, and protocol recruitment plans.
- Resolve escalated issues identified by the site activation subteam in partnership with the Study Manager.
- Work proactively with data management functions to ensure alignment on data flow and timely delivery.
- Forecast and manage the Clinical Trial Budget.
- Provide country and regional level input to country outreach surveys.
- Create awareness by working as a cross-functional Team Leader to deliver site intelligence initiatives with a variety of stakeholders, both internal and external.
- Approve and oversee drug supply management, manage the flow of drug supply to the sites.
- Evaluate study progress reports and results.
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
- Minimum Bachelor's Degree
- Applicable and relevant pharmaceutical industry experience
- Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
- Demonstrated project management/leadership experience
- Ability to evaluate, interpret and present complex issues and data to support risk
- Excellent communication skills, both written and verbal; must be fluent in English
- Effective decision maker, analytical and solution-oriented
- Proficiency in Microsoft Office Suite.