Senior Clinical Database Programmer (LATAM)

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru , and we’re looking for a Senior Clinical Database Programmer to help build the foundation of our clinical data operations in LATAM. In this high-impact role, you’ll lead the development, testing, implementation, and support of clinical databases from start-up through post-lock, while partnering closely with Data Management, Project Management, EDC vendors, and clients.

You’ll guide database design, oversee programming activities, troubleshoot complex technical issues, support system administration, forecast project needs, and contribute to SOP and process development. This is also a unique opportunity to mentor junior programmers, train end users, support onboarding, and influence how our new regional team grows.

Essential functions of the job include but are not limited to:

• Maintains responsibility of assigned projects. Ensures on-time delivery, communicates the status of projects to internal teams and study
• Maintains awareness of the key elements of the contract and scope of work for assigned project(s) and communicates status updates to the Project team as necessary.
• Perform project forecasting of hours, and identification of resource requirements and manages project budgets including identification of out-of-scope work and post production changes
• Provides input and guidance to the design of clinical databases to the client and internal teams
• Builds and supports clinical databases
• Develops, tests, and validates programs and clinical database to support client-related projects and third-party applications.
• Provides system administration and advanced technical support services for internally developed applications and clinical databases, client-related projects and third-party applications
• Troubleshoots and resolves software and clinical database problems
• Develops and maintains study-specific validation documents
• Provides support to data management for client-related projects from CRF design to post database close and archival
• May design, develop and validate the Company’s internal applications, client-related projects and third-party applications.
• Participate in software vendor selection
• Participate in conducting EDC demonstrations and trainings
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Supports with onboarding of new hires
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• Present software demonstrations/trainings, department/company training sessions, present at project meetings
• Performs all duties in accordance with SOPs, government regulations, guidelines and industry standards.
• May require some travel
• Perform other duties as assigned

Qualifications:

Minimum Required:

• Minimum 5 years’ experience
• Bachelors and/or a combination of related experience
• Professional working proficiency in English required

Other Required:

• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in Object Oriented Programming (C#, C++, VBS, etc.…)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
• Experience in clinical database management system development
• Experience in a clinical, scientific or healthcare discipline
• Proficiency in more than one CDMS system to include building forms, edit checks and complex rule development
• Awareness of CRF standards and input to maintenance of standards library
• Ability to troubleshoot and support peers with technical issues and build solutions
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong leadership and interpersonal skills

Preferred:

• Experience in a clinical, scientific or healthcare discipline and multiple therapeutic area experience, preferably Oncology
• Experience in utilizing various Database Programming systems

Skills:

Competencies:

• Ability to work independently, manage time and create plans to achieve project revenue and business goals
• Ability to work effectively with minimal direction; must be a self-motivated and self-directed individual who enjoys a challenging and dynamic work environment
• Team player willing to collaborate and share knowledge
• Highly organized
• Effective communication, interpersonal and negotiation skills
• Excellent organization and prioritization skills
• Exceptional customer service orientation and proven track record of successful client relationship management
• Conducts formal presentations to a wide variety of audiences including colleagues and clients with a high level of proficiency

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

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