SENIOR CLINICAL PROGRAMMER
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.
The Senior Clinical Programmer will be responsible for developing programs and databases that facilitate the collection and retrieval of clinical trial data for regulatory submissions and marketing claims.
The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don't miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate.
This position is either located in our Irvine, CA office or remote anywhere in the USA
- Design, create, validate, and modify clinical databases, and tools and programs for data validation checks, and clinical trial reporting.
- Lead cross functional teams in the design and delivery of moderately complex functional modules and provide data management expertise regarding clinical trials, protocols, and case report forms
- Establish the development of specifications for systems and/or processes, system upgrades and enhancements; and engage IT to deliver higher level support to users
- Develop and present training to end-users, including providing guidance to lower level Clinical Programmers in their training program development. End-users include, but not limited to, clinical study project teams, external clinical study users, junior-level Clinical Programmers, etc., as well as resolving escalated customer/user issues
- Establish the development of SOPs, company standards, and test scripts, and verify software specifications and system configurations to ensure the quality, compatibility, compliance of clinical systems, including working with external system vendors and service providers for clinical trials
- Bachelor's degree with 4 years experience in Computer Science, Information Systems/Technology, Statistics, Informatics, Mathematics or Engineering
- Experience in clinical research, data management, software programming, or related field is required
- Experience in programming complex custom functions in C# is required
- A minimum of 4 years of experience with Medidata RAVE is required
- Experience within the pharmaceutical, medical device or biotech industries required
- Extensive experience in migrations
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
- Excellent problem-solving and critical thinking skills
- Ability to manage competing priorities in a fast-paced environment
- Strict attention to detail
- Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on projects
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
- Proven expertise in Microsoft Office Suite
- Basic project management skills
- Full knowledge and understanding of policies, procedures, and guidelines relevant in the development of clinical databases
- Full knowledge of processes and procedures in clinical data management
- Full knowledge of relational databases, systems, and programming languages
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.