Start Up Project Manager II

📋 Description

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

• The SUPM will oversee one or more interventional studies across various therapy areas, including oncology, vaccines, internal medicine, rare diseases, or inflammation and immunology.

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

• Typically, the SUPM will take full ownership of medium to large-sized studies across all regions and countries, or for specific countries or regions within a global study where another SUPM is responsible for site activations throughout the entire study.

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

• Lead start-up meetings that promote alignment of site selection with activation activities undertaken 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 developing and managing the initial baseline and subsequent snapshots of timeline planning within the EPM system, which set the overall targets for site activation over time, aligning with the study's priority within the overall portfolio and the expectation to deliver according to plan with a high level of certainty.

• Expertly incorporate the requirements of protocol amendment(s) to ensure site activations are delivered as planned, with a focus on optimizing participant recruitment.

• Responsible for the integrity 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 complete activation of the last site in the study.

⛳️ Requirements

• Proven clinical research experience.

• Established start-up experience.

• Demonstrated project management experience.

• Global start-up experience (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 of the world.

• Technical proficiency in using software for managing clinical studies (including enterprise project management tools, both off-the-shelf and custom-built) along with reporting systems (dashboards with associated medium to complex data analysis).

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

• Conduct critical path analyses across multiple related project plans, utilizing key performance indicators to drive overall delivery to the operational plan across roles.

• Employ generative artificial intelligence techniques in daily tasks.

• Utilize risk management techniques as standard practice to identify and mitigate significant project delivery risks.

• A critical thinker with strategic planning, analytical, and problem-solving skills who positively adapts to rapid change.

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

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

• In-depth understanding of clinical trial methodology.

• Fluency in English is mandatory.

🏝️ Benefits

• Health insurance.

• Professional development opportunities.