Premier Research is looking for a Senior Data Manager - FS (Fixed Term 4 months) 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.
This is a 4 - 5 month Fixed-Term Contract requiring an immediate start. We kindly request that only candidates who meet these criteria apply
What you’ll be doing
- Assists 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
- Provide input to and review of Data Management Plans in support of clinical study deliverables
- Supports the development of CRFs and edit check specifications per protocol 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
- Prepares and maintains 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, as required
- Liaises with the sponsor as needed to resolve issues that cannot be resolved within the organization.
- Mentor and train Data Managers
- Performs additional duties as assigned
What we are looking for
- Bachelor's 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
- 5 to 7 years of practical experience 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.
- Proven ability to mentor others by instructing and developing capabilities
- 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
