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Clinical Outcomes Assessment (COA) Specialist

Berkshire   •  Negotiable  •  Contract/Temporary, Full time


Clinical Outcomes Assessment (COA) Specialist

12-month initial contract

Uxbridge (London) or Dublin based - Hybrid working available

70,000-85,000 per annum (DOE)

Inside IR35

Cpl Life Sciences are seeking a Clinical Outcome Assessment Specialist to work with a leading Pharmaceutical Company, who will be responsible for working directly with COA Manager to provide technical and general administrative support for assigned eCOA studies including but not limited to; managing and overseeing COA license agreement, supporting with managing COA translations, compliance monitoring, User Acceptance Testing (UAT) execution, documentation management (IRB/EC & TMF) and study decommissioning.Possessing strong attention to detail, effective communication skills and robust organizational abilities, the COA Specialist will work collaboratively with other business units (e.g. Clinical Trial Management, Procurement, Legal, Finance), external eCOA vendors and Clinical Research Organizations (CROs) to ensure timely completion of all study related activities.

JOB DUTIES:

Provides general day-to-day eCOA support working with vendors and internal cross functional teams

Ensure smooth study operation with strong communication skills escalating COA project operational risks to their manager

Reviews and monitors eCOA Compliance for one or more assigned studies, and advances issues related to compliance to the COA manager, contributes to compliance action plan development and implementation

Supports UAT strategy and execution by reviewing test plan, test scripts and conducting UAT.

Supports the coordination, management, and reconciliation of study related eCOA documentation in Trial Master File

Supports the COA Manager, with COA research to determine appropriate copyright holder and establish licensing requirements

Secure necessary clinical outcomes assessments permissions and license agreements (including Master Service agreements, where appropriate) to ensure alignment with new and/or updated license agreements through collaboration with the following internal functions: Legal, Procurement, Health Economics & Outcomes Research, Finance

Track and communicate licensing agreement status and serve as central point of contact for internal and external stakeholders for licensing agreements in clinical trials

Review licensing invoices for pass through costs in coordination with Clinical Study Lead and COA manager; and ensure payment of appropriate license fees is completed

Receive and catalogue source documents (English and translations) as received from the license holders and translation vendors

Track and maintain database of license holders, ensuring compliance with terms and conditions of relevant contracts

Provide support for problem resolution between licensing holder and study team

Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives

Proactively recommends process improvement initiatives for the department

JOB REQUIREMENTS:

General knowledge and awareness of systems development processes

Ability to acquire working knowledge of copyright law and licensing/permission requirements for COAs

Effective verbal and written communication skills

Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization

Ability to proactively recognize project challenges, implement action plans, and escalate risks in a timely manner

Strong organizational and attention to detail

Ability to support and build collaborative relationships both internally and externally

Basic familiarity of clinical drug development preferred

Bachelors degree and minimum of 3 years relevant industry experience.

If you have direct experience within eCOA and Clinical Assessment then please apply here or send your CV directly tojulie.ball@cpl.com

  • Agency: Cpl Life Sciences
  • Reference: JO-2206-494254
  • Posted: 7th June 2022
  • Expires: 5th July 2022

Cpl Life Sciences

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