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:
Creates electronic Case Report Forms (eCRFs) according to finalized protocols and study design specifications for Electronic Data Capture (EDC) studies
Creates data entry screens according to the approved annotated Case Report Form (CRF) for paper studies
Communicate with data management and study management teams throughout all study start up activities to ensure team needs are understood and met.
Designs, builds, and tests clinical databases according to Standard Operating Procedures (SOPs)
Programs field derivations, edit checks, consistency checks, validations, procedures and rules.
Writes data extraction programs
Develops of study reporting environment which includes CRF and non-CRF (loaded) data in addition to transforming collected data to required reporting format.
Produces database documentation including an annotated CRF
Ensures database documentation is maintained for the Trial Master File (TMF)
Works in collaboration with the sponsor and study team to define all technical elements of the Data Management Plan
Performs system testing and Quality Control (QC) of specified deliverables
May be required to participate in a flexible coverage schedule based on business need
What We Are Searching For:
Bachelor degree, or international equivalent from an accredited institution, preferably in a technical 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). Alternately, must have proven experience in all primary job functions.
1 to 2 years of SQL programming experience preferred
Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
Demonstrates excellent English verbal and written communication skills
Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
Familiarity with drug development and clinical trial processes preferred
Top Skills
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!
