AGATI CLINICAL INFORMATICS LLP
Location
India | India
Job description
The Senior Clinical Database Programmer I support study set-up tasks on EDC platforms.
Key Responsibilities:
. Perform clinical database build and testing on EDC platforms like Inform/Medidata RAVE/Medrio/ Vieodc.
. Lead and supervise and/or create, implement, and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC.
. Provides leadership, mentorship, training guidance, and support to department members.
. Develop the eCRF layout and program edit checks.
. Undergo trainings on ICH GCP, 21 CFR Part 11 guidelines, General Data Protection Regulation (GDPR)
. Undergo trainings on Quality Control procedures and Standard Operating Procedures (SOP)
. Ensure completion of training documentation on a timely basis and maintain compliance.
. Maintain the highest level of professionalism, learning, productivity, and quality.
. Adhere to quality requirements, achieve targets/volumes in given TAT (Turnaround time)
. Meet the goals and project objectives, as assigned by line manager.
. Adhere to compliance needs in terms of Time sheet submission & Attendance.
Education:
. Minimum Bachelors/master's degree in any discipline. Life Sciences or computer science is preferred.
Experience:
. Minimum 4-6 Year experience in Clinical Data Management.
. Must have basic clinical trial/Clinical Data Management knowledge.
. Knowledge on CDISC data standards is a plus.
. Knowledge on databases like Medidata Rave/Viedoc/Medrio etc.
. Must have core Rave Experience with hands-on on CRF Development, Dynamics, Edits and/or CF.
. Good Knowledge on Cloud Admin, Lab Administration, Site and User Administration, Especially Rave EDC.
. Good Knoweldge on Medrio Platform.
. C# Language is an add-on.
. Should have worked from Study start-up till Close-out Activities.
. Work Independently and with minimal dependency with utmost quality following the best practices and train the juniors.
Skills:
. Good written and verbal communication skills
. Ability to work collaboratively as part of a team.
Job tags
Salary
