Study Start - Up Project Manager responsible for managing start - up project strategy and site activations at Parexel. Collaborating across teams for regulatory submissions and study milestones.
About the role
- Study Start Up Project Manager at Parexel managing global start up project strategy across clinical trials. Collaborating with cross-functional teams and ensuring site activations to plan.
Responsibilities
- Define, develop and deliver the global start up project strategy by partnering with roles across GSSO, CD&O, Global Regulatory Submissions and others as required
- Take full responsibility for small to medium size studies located in a single country or region
- Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan
- Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
- Co-ordinate and oversee progress of study specific or country specific tasks that need to be completed for site activations
- Expertly integrate the requirements of a protocol amendment(s) to deliver site activations to plan
- Act as a key point of escalations for site activation related issues raised by country level start up roles
- Continually assess current and future workload to proactively anticipate, problem solve
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
- 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
- A scientific or technical degree is preferred
- Must have a BS/BA – 5 years relevant experience
- MS/PhD – 3 years relevant experience
Benefits
- Health insurance
- Retirement plans
- Paid time off
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