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 Staff Clinical Programmer will be responsible for clinical data management (CDM) systems and programming, and execution for multiple clinical trials using multiple computer systems. Strong experience in Rave Electronic Data Capture (EDC) programming, database design, and custom function programming, for the development of CDM systems.
Essential Job Functions / Key Responsibilities:
- Provide technical expertise in clinical programming functional area and lead in the development of clinical databases, and tools and programs for data validation checks, and clinical trial reporting in collaboration with key stakeholders.
- Lead cross functional teams in the design and delivery of complex functional modules and provide clinical programming expertise regarding clinical trials, protocols, and case report forms.
- Lead the development of specifications for systems and/or processes, system upgrades/enhancements and integration; and engage IT to deliver higher level support to users.
- Develop and present high level technical training to end-users, including providing guidance to lower level Clinical Programmers in their training program development.
- Identify resource needs for database implementation and participate in the evaluation of external resources/vendors
- Manage daily service providers’ activities for outsourced systems and services used in clinical trials.
- Participate in the creation and revision of new or existing SOPs, work instructions, workflow, forms, and templates to ensure clinical systems and activities are in compliance with the regulatory and company requirements.
- Other incidental duties assigned by Leadership.
Basic Qualifications and Minimum Requirements:
- Bachelor's degree with 6 years of Medidata RAVE clinical programming experience in the pharmaceutical, medical device or biotech industries, OR
- Master's degree with 5 years of Medidata RAVE clinical programming experience in the pharmaceutical, medical device or biotech industries
- Proven successful project management skills.
- Proven expertise in both Microsoft Office Suite, including advanced Excel and CDM (Clinical Data Management) systems.
- Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards.
- Extensive knowledge and understanding of policies, procedures and guidelines relevant in the development of clinical databases.
- Extensive knowledge of processes and procedures in clinical data management.
- Extensive knowledge of relational databases, systems, and programming languages.
- Extensive knowledge of clinical programming as it relates to business processes.
- Field of study in Computer Science, Information Systems/Technology, Statistics, Informatics, Mathematics, or Engineering
- Extensive experience in executing complex migrations
- Experience in programming complex custom functions in C#
- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
- Good presentation and facilitation skills.
- Ability to translate technical information to cross-functional teams
- Good leadership skills.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
- Ability to manage competing priorities in a fast-paced environment.
Additional Talents and General Expectations:
- Represents leadership on sections of projects within a specific area interfacing with project managers and team members.
- Consults in project setting within specific sections.
- Provides leadership to outsourcing partners on a task level.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.