Clinical Trial Associate, Study

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

For more information on SMPA, visit our website  or follow us on Linked In.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

For more information on SMPA, visit our website  or follow us on Linked In.

The Clinical Trial Associate for Study Start-up (SSU CTA) assists in the delivery of site start up activities for assigned studies from site identification through activation working in collaboration with the Clinical Study Lead (s) and is an active member of the study team(s).

The SSU CTA supports the collaboration with CPMs, CRAs, Clinical Business Operations, Medical Affairs, study sites, study team and CRO, if applicable, to ensure that site activation is achieved in a timely and efficient manner based on timelines set by the study team and in consideration of local activation process requirements.

Perform general administrative tasks to support team members with clinical trial execution, e.g., development and formatting of documents, review and reconciliation of study- specific information, etc.

Ability to work with timelines and complete tasks according to deadline.

Problem solving study-related issues; demonstrating resourcefulness and independence; escalation of issues as needed.

Assists the SSU Manager in generating and updating the study site activation plan across countries and sites based on the study priorities detailing country and site-specific requirements and planned dates.

Supports review of and modifications to the study start-up processes to ensure quality and efficiency.

Assists the SSU Manager in their applicable functions and CROs as applicable with regulatory interactions related to submissions and approval processes across multiple countries.

Collects and maintains essential documentation in compliance with ICH-GCP and ensures filing in TMF.

Tracks budget and contract negotiations/executions in collaboration with CPM, CBO and other relevant stakeholders (i.e., Legal, Clin Ops, etc.),

Assists the SSU Associate Director in producing and collecting site-specific contracts, ICFs and CDAs from country and/or master template.

Supports the SSU Associate Director in communicating site prioritization regarding Study Site Contract completion/execution to meet Study Activation Plan.

Tracks and reports metrics of study site progress towards activation at relevant meetings.

Proactively identifies delays in start-up activities, the risks to the activation plan and supports the SSU Associate Director in developing collaborative mitigation strategies for the study team to implement.

Perform other duties as assigned.

• Bachelor’s degree (scientific or healthcare discipline preferred) or equivalent industry experience
• A minimum of 1 year of related experience is preferred
• Strong Computer skills in Office, Word Excel, Project, Smartsheet, and other applicable applications.
• Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands.
• Excellent communication and interpersonal skills are essential as the CTA interacts with many people of varying levels of responsibility for clinical trial programs
• Able to collaborate effectively with internal and external study management teams to meet project timelines.
• Excellent writing skills to assist with creation of file notes, team communications, and other documents as assigned.
• Knowledge and experience with Trial Master Files (TMF) and experience with electronic TMF systems (i.e., Veeva) is preferred
• Knowledge of Site Start-up activities in clinical research is preferred

Primarily remote role with…