Life Sciences Consultant - #26-23832

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

The Clinical Outcome Assessment (COA) Operations and Patient Experience Data (PED) Study Management Consultant tasks include:

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). This includes but is not limited to, patient-reported, clinician-reported, observer-reported outcomes, performance measures, and digital health technologies.

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.

Study Execution:

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.

Communication and Collaboration:

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.

Regulatory, Quality and Compliance:

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.

Qualifications/ Required Knowledge/ Experience and Skills:

• 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.
• Experience in Otsuka Therapeutic Areas (i.e., immunology, nephrology, mental health, and/or neurology) preferred.
• 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.

Educational Qualifications:

• Bachelor’s degree in a relevant field (outcomes research, health services research, epidemiology, public health, community health, or related fields).
• Master’s degree in a relevant field preferred.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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