Clinical Outcome Assessment (COA) Operations Consultant

Clinical Outcome Assessment (COA) Operations & Patient Experience Study Management Consultant

Duration: 12- month Contract

Location: Remote
 

Position Summary

We are seeking an experienced Clinical Outcome Assessment (COA) Operations and Patient Experience Study Management Consultant to support the planning, implementation, and execution of patient-focused data collection activities across clinical development programs. This individual will oversee the operational delivery of Clinical Outcome Assessments (COAs) and patient experience initiatives within clinical trials, ensuring high-quality execution, regulatory compliance, and alignment with study timelines.

The ideal candidate brings a strong understanding of COA implementation, eCOA systems, vendor oversight, and cross-functional collaboration within pharmaceutical, biotechnology, CRO, or eClinical environments.

Key Responsibilities

COA Operations & Implementation

• Support the execution of Clinical Outcome Assessment strategies across assigned clinical studies and development programs.
• Coordinate implementation of patient-reported, clinician-reported, observer-reported, and performance outcome measures within clinical trials.
• Ensure timely completion of COA licensing, translation, linguistic validation, modality adjustments, and rater training activities.
• Lead operational implementation of in-trial patient interview activities and related study procedures.

eCOA & System Management

• Facilitate implementation and maintenance of electronic Clinical Outcome Assessment (eCOA) platforms.
• Partner with internal and external stakeholders to configure systems and embedded workflows.
• Lead User Acceptance Testing (UAT) activities and support issue resolution prior to study launch.
• Monitor change control activities and support ongoing COA data surveillance processes.

Vendor & Project Management

• Manage relationships with external vendors and service providers supporting COA activities.
• Track project timelines, deliverables, budgets, and quality expectations.
• Identify and escalate risks while driving solutions to maintain study milestones.
• Coordinate multiple projects simultaneously while ensuring successful execution.

Study Support & Evidence Generation

• Support activities related to the development and validation of COA measures using qualitative and quantitative methodologies.
• Contribute to literature reviews, interview studies, survey research, and psychometric evaluation efforts as needed.
• Partner with cross-functional stakeholders to execute patient experience initiatives that support clinical endpoint strategies.

Communication & Collaboration

• Serve as a key point of contact for COA-related operational activities.
• Collaborate with Clinical Operations, Data Management, Biostatistics, Regulatory, Procurement, and external partners.
• Communicate project updates, timelines, and study outcomes to internal teams and leadership.

Quality & Compliance

• Ensure all activities comply with applicable regulations, guidance documents, and organizational procedures.
• Support inspection and audit readiness activities and assist with remediation efforts when necessary.
• Maintain documentation and records in accordance with quality standards and Good Clinical Practice (GCP).

Qualifications

Required

• Bachelor’s degree in Public Health, Epidemiology, Outcomes Research, Health Services Research, Life Sciences, Psychology, or a related field.
• Minimum of 5 years of experience supporting Clinical Outcome Assessments (COAs) within clinical trials.
• Experience managing eCOA implementation and electronic clinical systems.
• Demonstrated experience working with vendors, CROs, or eClinical partners.
• Strong project management and organizational skills.
• Excellent written and verbal communication skills with the ability to work independently and collaboratively across functions.
• Knowledge of clinical development processes, regulatory expectations, and patient-focused data collection practices.

Preferred

• Master’s degree in a relevant discipline.
• Experience within pharmaceutical, biotechnology, CRO, or eCOA vendor environments.
• Familiarity with qualitative research methods, targeted literature reviews, and psychometric validation activities.
• Experience supporting therapeutic area programs in areas such as neuroscience, immunology, nephrology, or other specialty indications.