Available Positions

Sr. Manager, Clinical Outcome Assessment at Pharmaceutical Company in New Jersey, New Jersey, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • New Jersey, New Jersey, United States
  • 8/10/19

Job ID: 335606

Job Description

The Clinical Outcomes Assessment (COA) Manager is accountable for electronic COA (eCOA) in individual clinical research studies from study design to close out in collaboration with the study team. The COM is accountable for the eCOA project timelines, translation, eCOA study specifications, executing UAT, and ensuring collection of eCOA is in accordance with CLIENT Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight of eCOA will vary accordingly. Responsible for creating and enforcing eCOA systems standards, managing vendor performance, and supporting training & education of stakeholders. May participate in process improvement initiatives in global development.

 

Job Duties:

o Responsible & accountable for the successful delivery of eCOA for one or more clinical research trials with quality and compliance

o Responsible for reviewing and approving project related eCOA study documentation during the course of the Project Lifecycle

o Applies eCOA systems expertise on day-to-day activities when issues are escalated o Communicates with internal and external stakeholders and escalates risks

o Provides input into protocol development as it relates to clinical outcomes o May participate in creation of eCOA standards

o Define and support strategy for eCOA migration and COA validation

o Support Clinical Study Lead with license acquisition

o Responsible for eCOA and translation vendor selection, in collaboration with study team

o Oversee eCOA vendor performance at the clinical trial level, including oversight of KPI, performing root cause analysis and identifying corrective actions, and serving as point of escalation for eCOA issues.

o Uses interpersonal, negotiating, and project management skills to perform the following tasks as related to COA:

o Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all eCOA systems related issues and end of study vendor deliverables

o Risk management planning o Communication planning, information distribution, performance reporting, and project closure.

o Provides support for problem resolution between eCOA vendors and CLIENT study team

o Monitor financial components related to COA and Innovation for each study

o Collaborate with study team members on medical monitoring plan

o Collaborate with data management on eCOA data specifications, standards, and transfers o Provides training and mentors new staff

o Apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations

o Develop strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment

o Facilitates in communication of clinical innovations in eSource modalities to stakeholders and broader organization

o Support strategy for implementation of innovative clinical trial technologies and disruptive innovations

o Provide consultation on eCOA modality benefits, risks, costs and process o Facilitates and contributes to study level lessons learnedo Recommends and participates in cross-functional and departmental process improvement initiatives

Qualifications

Requirements:

o Demonstrate knowledge of eCOA systems development processes

o Demonstrated interpersonal & leadership skills

o Ability to understand and implement the strategic direction and guidance for respective clinical studies

o A data driven approach to planning, executing, and problem solving

o Effective communication skills via verbal, written and presentation abilities

o Ability independently perform and manage multiple tasks at one time and meet deadlines in a complex environment working both internal to CLIENT and external vendors

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