Start Up Project Manager II

This is a fully remote position, open to applicants in Canada.

📋 Description

• The Start Up Project Manager is tasked with defining, developing, and executing the global start-up project strategy by collaborating with various roles across GSSO, CD&O, Global Regulatory Submissions, and other relevant departments.

• The SUPM will be assigned to one or more interventional studies spanning several therapy areas, including oncology, vaccines, internal medicine, rare diseases, or inflammation and immunology.

• The SUPM will possess extensive knowledge in managing and coordinating global study start-up activities.

• Typically, the SUPM will assume full responsibility for medium to large studies across all regions and countries, or for specific countries or regions within a global study where another SUPM oversees the site activations for the entire study.

• The SUPM will collaborate with country-level start-up roles to identify opportunities to expedite site activations for their study.

• Lead start-up meetings that ensure alignment between site selection and activation activities conducted by country-level start-up roles in accordance with the endorsed trial optimization plan (approved by senior leadership).

• Accountable for the quality and completeness of start-up timeline plans at the study, country, and site levels within an enterprise project management (EPM) system.

• Responsible for generating and monitoring the initial baseline and subsequent snapshots of timeline planning within the EPM system, which establishes the overall targets for site activation over time, aligning with the study's priority in the broader portfolio and the expectation to deliver with a high degree of probability.

• Skillfully incorporate the requirements of protocol amendments to ensure site activations proceed as planned, prioritizing the optimization of participant recruitment.

• Responsible for the accuracy and quality of site activation timeline plans for each site, from the investigator initiation package sent for the first site in the study to the completion of site activation for the last site.

⛳️ Requirements

• Proven clinical research experience.

• Proven start-up experience.

• Proven project management experience.

• Global start-up experience, with exposure across at least North America, Asia, and Europe in multiple therapeutic areas.

• Ability to concurrently manage complex processes within and across countries in various regions worldwide.

• Technical expertise in utilizing software for managing clinical studies (both enterprise project management and custom-built solutions), including reporting systems (dashboards with associated medium to complex data analysis).

• Exceptional ability to understand status and tailor communications for a diverse audience.

• Capable of performing critical path analysis across multiple interconnected project plans and using key performance indicators to drive overall delivery to operational plans across roles.

• Will utilize generative artificial intelligence techniques in daily tasks.

• Employs risk management techniques as standard practice to identify and mitigate key project delivery risks.

• A critical thinker with strong strategic planning, analytical, and problem-solving abilities, able to respond positively to rapid changes.

• Extensive global start-up clinical trial/study management experience.

• Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical, and regulatory operations.

• Extensive understanding of clinical trial methodology.

• Fluency in English is mandatory.

🏝️ Benefits

• Health insurance.

• Professional development opportunities.