Job type full-time number of hires for this role 1
Us work authorization (preferred)
Full job description
Deltamed solutions, inc(dms), as a cro company, specializes in data management, biostatistics, and sas programmingOur clients and partners include pharmaceutical, biotechnology, medical device companies, and crosStriving for high quality, we focus on reducing the time, cost, and risk of bringing new pharmaceutical products to marketOur knowledge, experience, passion for what we do, and commitment to excellence are our products and our businessWe are currently looking for a qualified lead database programmer with the following qualifications:
The lead database programmer is responsible to manage and oversee the deliverables in database programming activities in accordance with schedules and agreed targetsMaintain process standards across the therapeutic areas according to deltamed/clients’ sops, global and china regulatory requirements and international ich guidelinesWork cross functionally and be responsible for maintaining and developing positive communications within study team as well as external customers.
Essential duties and responsibilities
Lead and provide effective guidance in database programming activities, including database design and testing, edit check programming and dm report and listings.
Design, program, test, and maintain the clinical trial databases and data entry screens using medidata rave, inform, ibm clinical or other edc systems in accordance with industry standards.
Program and/or validate validation/edit checks in edc, or sas and other programming tools.
Develop and/or validate standard or customized data listing reports and patient profile to assist data review purposes, using sas or other reporting tools.
Mentor junior database programmers to adhere to established database build standards.
Schedule and lead ecrf design and review meetings.
Routinely interface with cross-functional team members and external customers.
Proper management of project priorities and timelines.
Act as liaison with vendors, internal and client teams to prepare and establish external data transfer specifications (dts).
Retrieve the data from cro and external vendors and validate the adherence to agreed format and requirements.
Provide database design expertise and support to data management team.
Make data available to company personnel and regulatory agencies when required
Perform post processing of data extracts in accordance with industry standards to be delivered to biostatistics.
Develop, enhance, and maintain documentation and processes related to database programming and study startup/close out.
Adhere to the standard operational procedures and ensure appropriate documentation for areas of responsibility.
Bs/ba degree or equivalent in a relevant scientific discipline with a minimum of six years’ experience.
Detailed knowledge and experience in case report form design, central/local laboratories, programming databases, query resolution, data validation.
Advanced knowledge of clinical database design tools is a must (medidata rave and ibm clinical experience are most important)
Good communication skills are a must.
Ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers.
Knowledge of fda/ich guidelines and industry standard practices regarding data management.
Basic understanding of relational database structures.
Knowledge of sql, sas and other programming languages are a plus.
Custom functions experience is preferred.
Job type: full-time
Paid time off
8 hour shift
Monday to friday
Database programming: 5 years (preferred)
Medidata rave: 3 years (preferred)
Work location: remote