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 will 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 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
- 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
What we are searching 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 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
Additional details:
Fully remote position
Working hours: 11:00-19:00
Monday to Friday
Skills Required
- Bachelor’s degree or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field, or an equivalent combination of education, training, and experience
- 3 to 5 years of practical experience using commercial clinical data management systems or electronic data capture products, such as Oracle RDC, Oracle Inform, Medidata Rave, or DataLabs; alternatively, proven experience in all primary job functions
- Excellent English verbal and written communication skills
- Excellent computer skills in a Microsoft Windows environment, including proficiency with Microsoft Office tools
- Proven ability to drive successful customer experiences through positive interactions, quality and timely deliverables, and task ownership
- Strong analytical and organizational skills, with the ability to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
What We Do
We’re out to change the course of medical science. Are you ready to rise to the challenge? Premier Research is not about being everything to everyone. Instead, our deep, focused expertise targets the therapeutic areas and indications where today’s biotech and specialty pharma pioneers are doing the most amazing work. We’re 1,500 employees strong and operate in more than 20 countries, delivering unmatched expertise, operational skills, and dedication to meeting customers’ most challenging needs. Join us and meet some of the brightest minds in clinical development today — people who apply their best thinking to every project, recognizing that what they do significantly affects the lives and well-being of customers, patients, physicians, and colleagues. You’ll enjoy great benefits and very flexible working conditions in a company that values your contributions, rewards your achievements, and is committed to helping you reach your full potential. Are you ready to make a real difference and help us transform this exciting industry? Follow our company page for more information about us and the work we do, and check out our current openings for your next career move!
