Associate Data Manager - FS

Premier Research is looking for a Associate Data Manager - FS to join our Functional Services Provider (FSP) team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

Responsibilities:

• Assists Data Manager in preparing clean databases by performing a review of clinical trial data through the CDMS or external data listings to ensure all captured data follows the rules outlined by the protocol and Data Management Plan 

• Provide input to and review of Data Management Plans in support of clinical study deliverables 

• Generates queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates, and client representatives) to resolve problematic data identified during every aspect of the data management process 

• Reviews responses to queries for appropriateness, resolves any discrepancies, and modifies the database accordingly under supervision of the Data Manager 

• Supports the development of CRFs and edit check specifications per protocol as determined by the Data Manager and participates in user acceptance testing of CRFs and associated edit check specifications as required 

• Assists in the user acceptance testing for study-specific data listings ensuring data output adheres with requirements 

• Assists Data Manager in preparing and maintaining documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made. 

• Performs additional duties as assigned 

Requirements:

• Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field, or equivalent combination of education, training and experience 

• 0 to 3 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc).   

• 1 to 2 years practical experience in customer service 

• 1 to 2 years preferred experience in clinical research 

• Demonstrates excellent English verbal and written communication skills 

• Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc) 

• Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership 

• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities