Lead Data Manager - FS

Premier Research is looking for a Lead 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.

• What you'll be doing:

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Responsible for independently leading end-to-end data management activities, including but not limited to, accurate and timely database design, database setup (including CRF and Non-CRF collection tools), data cleaning, and data management documentation

• Prepares the data management plans (DMP), data validation plans, completion guidelines, data management reports and other documents as required 

• Participates in and coordinates study team review of CRFs for potential data collection, database structure, or data entry problems as well as to ensures all captured data follows the rules outlined by the protocol and data management plan 

• Manages the development of the data validation plan per the protocol and ensures user acceptance testing of CRFs and associated edit checks are completed in accordance with project timelines 

• Participates in and manages the progress of data cleaning activities including the generation and resolution of queries and discrepancies 

• Ensures the accurate and timely reconciliation of third party data with Clinical Data Management System (CDMS) data. 

• Tracks CRFs as they are processed through the Data Management department 

• Interacts with the Project Manager or designee on a continual basis throughout the course of the study, when applicable. 

• Liaises with the sponsor as needed to discuss issues and provide data management updates 

• Ensures the Trial Master File (TMF) is accurate and contemporary at all times throughout the lifecycle of the trial 

• Mentors and trains Data Managers 

• Performs additional duties as assigned 

• Ability to perform overnight business travel, up to 10%

• What we are Looking for:

• 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 

• 3 to 5 years of practical experience leading database management activities and using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc).  Alternately, must have proven experience in all primary job functions. 

• 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