Prin, Clinical Programming
Spectraforce
US
Remote
3 hours ago
Job Description
Position Title: Prin, Clinical Programming
Work Location: Remote
Assignment Duration: 6 months (Temp to Hire)
Position Summary:
The main function of the Prin, Clinical Programming is to design, develop, and maintain clinical databases in EDC systems to support business requirements.
Key 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.
Qualification & Experience:
• 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 our organization 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
Additional Information:
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)
• TSDV (Targeted Source Data Verification module)
• Custom Functions (must have hands-on development experience)
• Advanced Edit Checks/Data Validation Logic
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 55.00/hr.
Work Location: Remote
Assignment Duration: 6 months (Temp to Hire)
Position Summary:
The main function of the Prin, Clinical Programming is to design, develop, and maintain clinical databases in EDC systems to support business requirements.
Key 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.
Qualification & Experience:
• 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 our organization 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
Additional Information:
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)
• TSDV (Targeted Source Data Verification module)
• Custom Functions (must have hands-on development experience)
• Advanced Edit Checks/Data Validation Logic
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 55.00/hr.