[Hiring] Study Start Up Project Manager @Parexel

Role Description

The Start Up Project Manager is responsible for defining, developing and delivering the global start up project strategy by partnering with roles across GSSO, CD&O, Global Regulatory Submissions and others as required. The SUPM will be assigned to one or more interventional studies in one or more therapy areas such as oncology, vaccines, internal medicine, rare disease or inflammation and immunology. The responsibility of the SUPM typically ends when all investigative sites are activated and ready to enroll participants, however this can extend further into the participant recruitment period to specifically deliver the implementation of protocol amendments across active sites for selected studies. The SUPM will have a comprehensive knowledge of managing and coordinating study start up activities globally.

• The SUPM typically takes full responsibility for small to medium size studies located in a single country or region, or for selected countries or region(s) within a larger global study.
• The SUPM is the leader of the start up sub team for the study, region(s) or countries assigned.

Qualifications

• Country or Regional start up exposure/experience in the countries under responsibility across at least two major therapeutic areas.
• Technical expertise in use of software (off the shelf and custom) for the management of clinical studies with prowess in using reporting systems (dashboards and associated basic data analysis) to comprehend and communicate status.
• Ability to use basic generative artificial intelligence techniques in daily work.
• Fluency in English is required.

Requirements

• Extensive global start up clinical trial/study management experience.
• Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations.
• Extensive knowledge of clinical trial methodology.
• Demonstrated start up experience.
• Demonstrated project management experience.

Company Description

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.

• We take our work personally, we do it with empathy and we're committed to making a difference.

Education

• A scientific or technical degree is preferred.
• Must have a BS/BA – 5 years relevant experience.
• MS/PhD – 3 years relevant experience.