UBC are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products. Our services range from supporting the largest brands in the industry, to providing fully outsourced functional services, to the most recently approved genetic therapies in orphan populations. The work we do positively impacts patients’ lives all over the world.

This role is part of our FSP model and on a Fixed Term or a Contract (freelance) basis 

Brief Description:   

We are looking for a Manager Clinical Outcome Assessment (COA), who will be responsible to define and oversee the execution of strategies for the development and implementation of COAs across our portfolio of RWE and clinical studies. 

The COA manager makes the bridge between the Consumer Sciences Team and different functional groups within the clinical research department to ensure the appropriate development and implementation of COAs in the study.

Specific job duties:

Apply technical expertise in support of RWE and clinical study to define and implement COA strategies, acting as the centralized contact for end-to-end COA implementation in a studyWorks cross-functionally (e.g., Consumer Sciences SMEs, RWE and clinical sciences teams, clinical operations, biostatistics, data management) to ensure COAs are defined, implemented, and analyzed appropriately in clinical or RWE studies, including:supporting the RWE or clinical scientist in the identification and selection of COAs measuring self-reported endpoints in the studywriting relevant portions of the study protocolsensuring copyright clearance and license agreements are obtained for COAsreviewing and ensuring quality of COA-related documentation prior to filling in the study TMFtraining internal study team members and investigative site personnel on COA principlessupporting the electronic migration of COAs and translations (user acceptance testing)collaborating with statistical teams to ensure that COAs are appropriate analyzed and described in statistical analysis plans, study reports.Manages and coordinates all vendors involved in the development, adaptation, and translation of COAs in clinical and RWE study including managing the contracting processes, overall budget, timelines and quality of deliverablesOversees quality at all levels of the end-to-end implementation of COAs in RWE and clinical studies, ensuring processes and procedures are followed as described in SOPs of Consumer Sciences Team.Collaborates with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles, proactively contributing to problem solving and resolution efforts.

Supervisory Responsibility:  

N/A but subject to review and change

Desired Skills and Qualifications:

Master’s degree in psychology, psychometrics, social sciences, outcomes research, public health, Epidemiology or a closely related disciplineMinimum 3 years of experience in a related roleDemonstrated experience with COA development and validation projects, including linguistic validation, in a regulated environmentExperienced with COA requirements for regulatory agencies, including a strong understanding of the US FDA Patient Reported Outcomes GuidanceProficient knowledge of GCP/ICHStrong planning/project management skills Excellent verbal, written, communication and interpersonal skills, with stakeholder engagement from operations through executive levels

UBC are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products. Our services range from supporting the largest brands in the industry, to providing fully outsourced functional services, to the most recently approved genetic therapies in orphan populations. The work we do positively impacts patients’ lives all over the world.