Develop and maintain trial specific database applications and data warehouse (e.g. Oracle Life Science Hub - LSH), including eCRF’s and database specifications, program validation and derivation procedures within the clinical database management (such as OC/RDC, Inform, Rave) using relevant programming languages (SQL, PL/SQL, C #, VB script, SAS) system in support of in-house and outsourced trials globally, of various levels of complexity for Phase I-IV independently or with minimal supervision.
Support special projects of limited scope (sub team lead, local project, etc.) both clinical and non- clinical in nature.
Provide study level expertise and involvement in CTTs.
Develop the eCRF layout and corresponding database according to documented trial specific requirements using components from existing libraries.
Perform Study setup activities within LSH. Responsible for the maintenance and daily operational support of LSH Data Warehouse system. Manage the Load, Transfer and Conformance of Clinical Trial data to the NCDS Standards.
Manage the Load, Transfer and Conformance of Clinical Trial data to the NCDS Standards. For assigned Clinical trials initiate data load from OC/RDC source into the Data Warehouse and communicate with all affected parties including Quality Manager, Data Manager, Database Programmer, CRO personnel and Third Party vendors.
Participate in Data Conformance and Data availability meetings and provide the necessary inputs on the daily operational activities.
Need to have basic understanding of Metadata management and impact of data elements within Metadata and the potential impact on the study activities.
Work and collaborate closely with External Data Loaders and ensure that the third party data for their studies gets loaded successfully.
Create, test and maintain trial specific plausibility and consistency checks.
Provide data transfer specifications for third party data. Maintain and update the eCRF application and its components as required for protocol amendments or required postproduction changes.
Develop departmental specifications and provide support for outsourced trials.
Create, file and maintain appropriate trial documentation.
Program and test procedures, of various levels of complexity, according to documented trial specific requirements, within the clinical database management system using relevant SQL, PL/SQL, C#, VB script, SAS
Maintain and update procedures as required for protocol amendments or required post production changes.
Creation and Execution of trial design reports based on trial metadata. Good knowledge of Novartis Clinical Data Standards. Understanding of Data Models and implementation for database deliverables.
Act as a trainer/mentor to new or less experienced associates on specific task(s). Contribute in the development and maintenance of project specific libraries.
At least 6 years’ experience in clinical database programming, setup of clinical databases and CRF design, and procedure /validation programming, as part of the setup of clinical databases, gained in the pharmaceutical industry, CRO or Life science related industry as well as the following:
- Strong management and Rave Study Build skills.
- Expert Custom Function programing is mandatory.
- It would be advantageous to comprehend the Medidata Rave Object Model.
- Excellent interpersonal skills.
- Demonstrate capacity to multitask and work in a fast-paced workplace.
- Effective communication skills
- Strong problem-solving and analytical abilities.
- Strong focus on providing high-quality results while paying close attention to the details.
- Highly effective capacity to foresee project-related issues and to create and carry out solutions.
- Outstanding interpersonal abilities.
- English proficiency in both writing and speaking.
- Extremely well-organized and goal-oriented.
- Advanced Excel and Word skills.
