RISK MITIGATION

• Co-ordinates across the study team and extended partners to deliver site activations to plan for the study or regions/countries assigned, assesses the ongoing site activation readiness status as well as proactively identifying and mitigating risks
• Act as a key point of escalations for site activation related issues raised by country level start up roles, seeking to firstly resolve issues directly or triage appropriately to other SUPMs on the study or the study management team, will always follow through to resolution

REQUIRED SKILLS:

• 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

REQUIRED KNOWLEDGE AND EXPERIENCE:

• 5+ years 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
• Prior Experience Preferred: Demonstrated start up experience, Demonstrated project management experience

REQUIRED EDUCATION:

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

  LI-CF1

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 I 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 I is the leader of the start up sub team for the study, region(s) or countries assigned.