Life Sciences Consultant - #26-23832

US Tech Solutions • Princeton, NJ

1d

About The Position

The Clinical Outcome Assessment (COA) Operations and Patient Experience Data (PED) Study Management Consultant will support the execution of the global COA strategy for assigned assets and indications. This role involves managing the implementation and operationalization of COA measures in clinical trials, including licensing, translation, validation, and training. The consultant will also manage vendor relationships, oversee project timelines and deliverables, and facilitate eCOA support. Additionally, the role supports the generation of COA evidence using qualitative and quantitative methods, tool development, and validation activities. The consultant will represent the PED&COA function in communications and ensure compliance with all applicable laws and regulations.

Requirements

• Strong knowledge of clinical development, regulatory requirements for clinical trials, COA, and patient experience data.
• Ability to collaborate with cross-functional teams and external collaborations to advance patient-focused drug development across multiple programs.
• Strong/effective verbal and written communication skills; ability to work independently.
• Project management experience, preferably in a research setting.
• At least 5 years demonstrated expertise in operations and management of COAs in clinical trials and e-clinical systems (eCOA[OD6.1]) with prior experience working in industry, CROs, or eCOA vendors.
• Understanding of non-interventional study methodologies such as targeted literature review, qualitative research, or psychometric analyses.
• Bachelor’s degree in a relevant field (outcomes research, health services research, epidemiology, public health, community health, or related fields).

Nice To Haves

• Experience in Otsuka Therapeutic Areas (i.e., immunology, nephrology, mental health, and/or neurology) preferred.
• Master’s degree in a relevant field preferred.

Responsibilities

• Support execution of the global Clinical Outcomes Assessment (COA) strategy under the guidance of the PED & COA Strategy Lead for the assigned asset(s) and indication(s).
• Partner with Clinical Management and Sourcing to ensure licensing, translation, linguistic validation, and modality adjustment/validation of COAs, including rater training, are completed in a timely manner as needed for the respective clinical trial.
• Facilitate the implementation of COA measures used in clinical trials.
• Lead implementation and conduct of in-trial interviews.
• Manage vendor relationships to ensure the timely and high-quality completion of assigned COA and PED-related tasks and projects.
• Oversee project timelines, deliverables, and quality standards, while fostering good partnerships with external collaborators.
• Facilitate eCOA support, including vendor management, system configuration and lead User Acceptability Testing (UAT) of electronic systems related to COA.
• Ensure proper embedded workflows for COA data surveillance, monitoring, and change control.
• Support the generation of Clinical Outcome Assessment (COA) evidence using qualitative and quantitative methods in line with international scientific standards and health authority guidance and regulations.
• Support COA tool development and validation activities to achieve "fitness for use" in informing endpoint models for pivotal clinical trials (e.g., validation of primary/secondary outcome measures using literature reviews, focus groups/interview studies, survey studies, psychometric studies, etc.).
• Manage individual COA Operations and PED Study Management projects and partner with the PED & COA Strategic Leads to ensure the implementation of project timelines and deliverables.
• Represent the PED&COA function and effectively communicate study plans, methodologies, and results to internal and external teams, including global and regional forums, as needed.
• Serve as a point of contact for COA-related clinical trial and operations communications within the organization and with external partners.
• Ensure compliance with all applicable laws, regulations, and regulatory guidance in all COA-related activities.
• Provide support during audits and address any findings to ensure alignment with international and regional requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level