Study Manager

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Responsibilities

• General Accountabilities Build and maintain engagement with Investigators, other site staff in collaboration with other functions, to ensure trial speed and effective start up, conduct and close out.
• Ability to manage studies and processes to agreed quality and timelines.
• Knowledge of the clinical development process, understand concepts and principles of study design, and application to manage and run studies.
• Compliance with Parexel standards Complies with required training curriculum.
• Completes timesheets accurately as required.
• Submits expense reports as required.
• Updates CV as required .
• Maintains a working knowledge of and complies with Parexel processes, ICH- GCPs and other applicable requirements.

Requirements

• Strong Communication Skills.
• Keen problem-solving skills.
• Fluent in both oral and written English.

Key Accountabilities

Ability to proactively identify & mitigate risks around study/site level in study execution.

Skills

Previous experience in scientific and/or regulatory medical writing.

Knowledge and Experience

Fluent in host country language required. At least 5 years in clinical practices.

Education

Minimum of BS/BA in a biomedical discipline or equivalent education/training is required.