Clinical Solutions Analyst

Found in: beBee S US - 2 weeks ago


Raleigh, United States UCB Full time

 

Make your mark for patients

 


We are seeking to hire a Clinical Solution Analyst who understands clinical trial processes, software solutions used to execute clinical trials, and computerized systems validation to join our team managed out of Raleigh, NC.   This position will not be remote and will require access to our Raleigh, NC offices.

 

About the role:

The Clinical Solutions Analyst has 2 fundamental responsibilities.  They will work closely with the business users to ensure the usersâ expectations are being met by the available technologies, and they will provide ongoing validation services to ensure that their solutions remain in compliance with corporate and regulatory expectations.   Solutions managed within the team include electronic trial master files (eTMFs), clinical trial management system (CTMS), electronic data management (EDC), electronic patient report outcomes (ePRO), clinical trial operational reporting and more.

 

Who youâll work with:

Analysts within the team will work with relevant business users (clinical project managers, clinical research associates, data managers, etc.) to understand solution requirements, develop and document business processes, and provide ongoing engagement to support the solutions.   We also work closely with counterparts in the Information Technology (IT) organization who have primary responsibility for the technical aspects of the implemented clinical solutions.

 

Within the Clinical Solutions team, youâll work with peers to support and enhance best practices that enable the successful management of UCBâs clinical trial technology solutions.  The geographically diverse nature of our various stakeholder groups may mean limited in-office engagements are required.

 

What youâll do:

  • Build/Execute user engagement plans to capture and deliver on stakeholder expectations
  • Develop/Maintain user requirements, performance qualification (PQ) and other validation documents and activities
  • Develop/Deliver training
  • Support audits and inspections as needed for your solutions

 

Interested?

For this role, weâre looking for someone with:

  • 7+ years of experience at a pharmaceutical/biotechnology company or CRO
  • 5+ years with relevant experience*.  7+ years if you donât have at least a 4-year degree

 

*Relevant experience means working with solutions like Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Metadata Repository (MDR), electronic Trial Master File (eTMF), electronic Patient Reported Outcomes (ePRO) and more, and performing GxP-aligned validation activities. 

 

Salary Range:  $100,640 to $132,090

 


Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities. 

 

As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 
 
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

 

Requisition ID:â¯86746â¯Â 

Recruiter:â¯John Gasbarreâ¯Â 

Hiring Manager:â¯Dave Donald Handelsmanâ¯Â 

Talent Partner:â¯Cornelius Luedtke

Job Level: SA I 

Please consult HRAnswers for more information on job levels.


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