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We are seeking a Clinical Programmer to work remotely for a client project.  Experience with Metadata and C# is required.  No 3rd party (C2C) can be considered.

Summary:
The main function of the Prin, Clinical Programming is to design, develop, and maintain clinical databases in EDC systems to support business requirements.

Job Responsibilities:
• Provide technical expertise in clinical programming functional area and lead in the development of clinical databases. Development includes tools and programs for data validation checks, custom functions (C#) and clinical trial reporting in collaboration with key stakeholders
• Lead cross functional teams in the design and delivery of complex functional modules (e.g. TSDV, BO4 etc.) 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.

Qualifications:
• Bachelor's Degree or higher related field with 8-10 years of previous related experience in clinical research database programming, data management, software programming or related field or equivalent work experience based on Edward's criteria Required or
• Deep subject matter expertise in Medidata EDC including C# custom function development
• Proven successful project management skills
• Proven expertise in both Microsoft Office Suite, including advanced Excel and CDM (Clinical Data Management) systems
• 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

Soft Skills:
• Strong team orientation with the ability to collaborate effectively across cross-functional clinical teams.
• Willingness to balance high-level technical work with detailed documentation and administrative responsibilities.
• Ability to work with a sense of urgency and contribute quickly in a fast-paced environment.
• Clear and proactive communication, especially when working with distributed teams.

Top Priorities for Success in Role
Candidates must demonstrate hands-on experience in the following areas:
• Medidata Rave (Metadata) – New Study Builds (required)

• Strong Medidata database experience required with C# custom function experience needed.
  • TSDV (Targeted Source Data Verification module)
  • Custom Functions (must have hands-on development experience)
  • Advanced Edit Checks/Data Validation Logic
  Candidates without direct experience in these areas, particularly custom function development within Medidata, will not be considered for this level.
  
  Exceptional Candidate Consideration:
  For candidates who demonstrate significantly advanced experience, senior-level expertise, and full alignment with all required technical competencies, there may be flexibility to consider submission up to a higher bill rate.
  
  This applies only to candidates who:
  • Meet all required qualifications
  • Demonstrate deep expertise (e.g., advanced custom functions, metadata study builds, TSDV advanced edit checks)
  • Are operating at a Principle to Senior Principal level
  
  Additional Role Considerations:
  Time Zone Preference:
  • Pacific Time Zone preferred to align with the core team.
  • Fully remote candidates will be considered.
  • Conversation to full-time may require alignment with hybrid expectations, provided that the opportunity presents itself.