We are looking for an experienced professional with robust programming competencies (SAS, SQL, Python, R, etc.) & strong communication skills for our Clinical Database Development Reporting & Analytics function. As a member of this function, you would be primarily responsible for seamless end to end data flow of Clinical & Operational Data from Data Collection, Transformation, Reporting & Analytics & provisioning of data to downstream applications & teams.
Your responsibilities include, but are not limited to:
- Serves in a support roles on multiple studies or as a lead for a study (with supervision/ mentoring)
- Leads the effective and timely development and implementation of clinical systems for assigned studies.
- Uses database programming techniques to create study specific validations
- Understand and copy/create study level metadata to compliment data provisioning in compliance with global standards.
- Develops database and conducts database testing.
- Develops data models to support data review and acquisition standards to adapt for study/project level needs and specificities.
- Establishes and maintains working relationships with Data Operations.
- Acts as a technical consultant ensuring appropriate development, maintenance, and use of all system capabilities such as electronic data capture, database programming, edit check programming, report programming, electronic data load, interactive response technology, electronic patient reported outcomes, metadata management and other clinical database development activities.
- Ensures that systems meet regulatory requirements, internal standards and are deployed with quality.
- Participate in improvement initiatives and/or non-clinical projects.
- Communicate and ensure that study objectives and priorities are met according to agreed timelines, strategies, quality and scientific standards.
- At least 2 years of experience in setup of clinical databases/Data Warehouse using RAVE or OC-RDC or LSH.
- Excellent interpersonal and written and oral communication skills, with the ability to effectively communicate cross-functionally
- Advanced technical skills: a. Good knowledge of EDC - Medidata RAVE preferred b. Excellent understanding of relational databases c. Microsoft Office Suite d. Knowledge of other programming languages such as SQL, PL/SQL, VBscript, SAS, C# or Java preferred
- Demonstrated ability to consistently produce detailed, high quality deliverables in a team environment
- Good problem-solving, negotiation and conflict resolution skills
- Good understanding of Drug Development Process, ICH--GCP and Health Authority Guidelines & Regulations
- Ability to effectively support and contribute to initiatives requiring Clinical Database acquisition tools and design expertise