Principal Global Trial Associate

Job Summary

This role will report into a line manager within Global Trial Management. The GTA can potentially support any therapeutic areas and research phase and will collaborate with cross-functional global teams to execute assigned operational aspects of global clinical research studies from protocol development to final clinical study report.

Responsibilities

• Contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities regulations/guidelines, and applicable SOPs/WPs.
• Provides operational input on development, management and maintenance of study deliverables (i. e. timelines, study plans, documents, etc. ) through collaboration with internal and external stakeholders.
• Primarily works on routine to complex projects/trials at varying stages and supports multiple complex trials as needed.
• Contributes to achieving corporate and study team goals, successfully completes assigned tasks, participates in service provider oversight, and sets priorities with guidance.
• Manages the development and/or collection of study level documentation and support Global Trial Lead (GTL) in ensuring eTMF accuracy and completion for all studies.
• Proactively manages multiple assignments and operational processes with moderate to minimal supervision.
• Manages country planning, protocol level attributes and milestones/drivers in CTMS.
• Has high functional impact on the study team and the organization.
• Support Global Trial Lead (GTL) in tracking of non-clinical supplies
• Support Global Trial Lead (GTL) in vendor management related activities

Project Management

• Manages the development and/or collection of study level documentation support Global Trial Lead (GTL) in ensuring eTMF accuracy completion of for all studies
• Provides operational input and facilitates operational processes as an SME in support of the startup, maintenance, and closure of studies.
• Uses performance metrics and quality indicators to assist the Global Trial Lead (GTL) in driving study execution.
• Proactively Identifies risks and develops/implements action to avoid or mitigate.
• Resolves routine problems and escalates important issues appropriately (with a sense of urgency).
• Actively contributes as a key functional member on cross-functional teams.

Study/Project Planning, Conduct and Management

• Provides and support input to study level tools and plans while working with moderate to minimal supervision, including but not limited to the Transfer of Obligations to Regulatory authorities.
• Study Sharepoint/study directory updates and the Global Vendor Site List etc.
• Independently performs core Global Trial Associate (GTA) tasks and escalates/pushes back/delegates appropriately.
• Simple studies or studies in closure phase may be managed in alignment with OPL or GTL.
• Reviews vendor invoices and lead approval process or submits to GTLs for approval (as needed); manages accruals and LSD/SOW changes.
• Actively contributes to study meetings by leading assigned topics/components.
• Assist the Global Trial Lead (GTL) in driving study execution.
• Contributes to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC approvals/notifications.
• Flexibility to work on various trials at varying stages/complexity with minimal guidance as needed.
• Understands strategy and decision making at program level and their impact on the studies.
• Ability to contribute to initiatives for process development and improvement.
• Ability to assess a situation and identify path forward with the appropriate resources.
• Understands interdependence of tasks assigned.
• Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.
• Supports study specific CSR appendices, as needed.
• Manages vendors and site payment processing and tracking.
• Lead assigned study closure/archival activities during study closure phase.