DBMS Consulting is hiring 4 full time employees on a contingency basis for its major pharmaceutical client in Princeton, NJ. The jobs require a minimum of 3-4 days on-site and 1-2 days remote work. MUST BE ELIGIBLE AND AVAILABLE TO WORK ONSITE IN NJ, USA. Travel costs can be reimbursed for weekly commute. Some portion of medical can be reimbursed depending on salary. Salary depends on experience.
Extensive experience with the development and management of clinical databases (Phase 1- 4) in the Pharmaceutical industry using Clinical Data Management System(s) (i.e. Primarily Medidata Rave or Oracle Clinical with Medidata Rave)
Building of database structures / data entry forms using Medidata Rave
Programming of edit checks and derivations
Configuration Mapping for study integrations including: Safety Systems, Consolidated Clinical Views (CCVs), CTMS/Rave Configuration.
Troubleshoots issues with Medidata, working with the Medidata as needed
Serve as a primary technical point of contact for assigned studies & provide technical support during study execution and closure
Support protocol amendments and database enhancements by:
Making modifications/additions to database structures/data entry forms
Modifying/adding necessary edit checks and derivations
Updating any/all configuration mappings for study integrations that is impacted by the database changes
Developing a Test Migration Plan and performing all necessary testing in the electronic CRF Amendment process in Rave, including creating the test migration plan, performing the impact analysis & reconciliation of changes the database structures, new and existing production data before deploying the changes into Production.
Support the clinical data snapshot process & other database lock procedures.
Generates and maintains all required documentation, including CRF Annotations, approval forms & supporting configuration reports, in support of database build and maintenance
Helps ensure QC of deliverables related to study setup and maintenance in accordance with ICH-GCP, SOPs and company standards
Promotes teamwork within study & functional teams, shares experiences and best practices
Serve as a subject matter expert for study build/database development
Has practical experience with various software tools and technologies such as but not limited to PL SQL, C#, UNIX, SAS, JReview, MS Office Products, etc
Knowledge of general clinical research and of the pharmaceutical industry.
Works collaboratively with Custom Function programmers, Data Management and multiple functional groups to complete programming tasks per agreed upon timelines.
Responsible for all related deliverables, addressing issues and meeting timelines.
Liaison with stakeholders such as clinical study team, data management, biometrics and IT during study execution, protocol amendments and study lock.
Liaising with business and study builders/database developers in India.
Liaising with Medidata.
Is a member of the study team, attends meetings, participates in discussions, uses an analytical approach to problem solving with a focus on quality deliverables.
May provide mentorship to peers.
4 to 6 years database development experience in the pharmaceutical industry working with clinical trial data.
Bachelor's degree, preferably in computing or scientific discipline
Clinical trial knowledge is required.
Medidata Rave Study Builder certification with at least 3 years of hands-on experience building studies in Rave.
Experience or knowledge of Rave Safety Gateway, TSDV is a plus.
Thorough understanding of regulations, GCP, ICH Guidelines as they apply to creation and maintenance of clinical databases.
Practical experience with programming using Visual Basic, APEX, PL SQL, XML, SAS, Java an advantage.
Excellent communication skills, organized and ability to lead tasks from concept to delivery.
Additional Salary Information: Incentive based bonuses available
Internal Number: DBD001
About DBMS Consulting, Inc.
DBMS Consulting was incorporated in 1997. As an organization which is specialized in the implementation and deployment of Oracle Health Sciences (OHS) and Oracle E-Business Suite (EBS) Applications DBMS Consulting has performed over 100 installations for its clients globally. Its clients include Global Pharmaceuticals, CROs, Biotechs, Medical Device Companies, Academic Institutions and Government Institutions throughout the U.S., Europe and Asia.