Sr. Database Developer
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Sr. Database Developer to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.Responsible for the configuration of project databases, tools, and utilities using Clinical Data Management Systems (CDMS) and underlying database platforms for the purposes of capturing accurate clinical trial data
- 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
- Communicates 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 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 assist in maintaining the Clinical Data Management Systems global and program libraries
- May be required to undertake additional programming tasks as needed
- May be required to participate in a flexible coverage schedule based on business need
- Liaises with the sponsor as needed to resolve issues that cannot be resolved within the organization.
- Mentor and train Database Developers.
- Performs other duties as assigned
- Bachelor degree, or international equivalent from an accredited institution, preferably in a technical 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.
- 1 to 2 years of SQL programming experience required
- Proven ability to mentor others by instructing and developing capabilities
- 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