COA Operations & Patient Experience Consultant

Us Tech Solutions; Princeton (NJ); On-site; USD 110,000 - 170,000; Full time

Job summary

US Tech Solutions is seeking a Clinical Outcomes Assessment (COA) Operations and PED Study Management Consultant to support global COA strategy and trial execution. You will partner with management, sourcing, and external vendors to ensure timely validation, training, and UAT of COA tools, while overseeing timelines and deliverables across assets and indications.

The role requires at least 5 years in COA operations within clinical trials, strong regulatory knowledge, and the ability to work

Qualifications

• Strong knowledge of clinical development, regulatory requirements for clinical trials and COA.
• Ability to collaborate with cross-functional teams and external collaborations.
• Excellent verbal and written communication; ability to work independently.
• Experience in Otsuka therapeutic areas preferred.
• Project management experience in a research setting.
• At least 5 years in COA operations and e-clinical systems.
• Understanding of non-interventional study methodologies.

Responsibilities

• Support execution of the global COA strategy for the assigned assets and indications.
• Partner with Clinical Management and Sourcing to ensure licensing, translation, and validation tasks are completed timely.
• Facilitate implementation of COA measures used in clinical trials.
• Lead in-trial interviews and manage vendor relationships.
• Oversee timelines, deliverables, and quality standards with external collaborators.
• Facilitate eCOA support, vendor management, and User Acceptability Testing.
• Ensure COA data surveillance and change control.
• Represent PED/COA in study plans and communicate results to teams.

Skills

COA knowledge

Regulatory knowledge

Cross-functional collaboration

Communication skills

Project management

Otsuka experience

Education

Bachelor’s degree in related field

Master’s degree preferred

Tools

eCOA systems

Regulatory platforms

Job description

US Tech Solutions is seeking a Clinical Outcomes Assessment (COA) Operations and PED Study Management Consultant to support global COA strategy and trial execution. You will partner with management, sourcing, and external vendors to ensure timely validation, training, and UAT of COA tools, while overseeing timelines and deliverables across assets and indications.

The role requires at least 5 years in COA operations within clinical trials, strong regulatory knowledge, and the ability to work