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Study Start Up Project Manager - FSP

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Parexel

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Location:
Canada , Remote

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Category:
IT - Administration

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Contract Type:
Employment contract

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Salary:

Not provided
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Job 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 will typically take 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 where another SUPM is responsible for the site activations of the entire study. The SUPM is the leader of the start up sub team for the study, region(s) or countries assigned.

Job Responsibility:

  • 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
  • Manage and coordinate study start up activities globally
  • Lead the start up sub team for the study, region(s) or countries assigned
  • Partner with country/site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan
  • Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions to align country and site activities
  • Continually assess current and future workload to proactively anticipate, problem solve and request appropriate changes
  • Provide project management of activities directly required to complete all site activations
  • Lead start up meetings that facilitate alignment of site selection to activation activities
  • Work with country level start up roles to seek opportunities to accelerate site activations
  • Accountable for quality and completeness of start up timeline plans at study, country and site level
  • Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning
  • Responsible for ensuring consistent participant compensation for sites and institutions
  • Expertly integrate the requirements of a protocol amendment(s) to deliver site activations to plan
  • Responsible for delivering site activations to plan
  • Responsible for the completeness and quality of site activation timeline plans
  • Coordinates across the study team and extended partners to deliver site activations to plan
  • Act as a key point of escalations for site activation related issues

Requirements:

  • 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
  • Will use standard risk management methodology to identify and mitigate key risks
  • Fluency in English is required
  • 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
  • A scientific or technical degree is preferred
  • Must have a BS/BA – 5 years relevant experience
  • MS/PhD – 3 years relevant experience

Nice to have:

A scientific or technical degree is preferred

Additional Information:

Job Posted:
May 14, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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