Programmer, Clinical Data

Overview

• Supports under general direction of more senior colleagues modern clinical behavioral measures and clinical outcome methods development.
• Supports post-market studies and studies along clinical regulatory requirements.
• Contributes to the specification, development and verification of audiological, technical or surgical functionalities within software and / or hearing system solutions.
• Acts as main point of contact for laboratory equipment and controlled devices in laboratory room.

What you’ll do :

• Works collaboratively with clinical research associates, vendors, statistical programmers, clinical, safety, regulatory, and project management functions to meet data management deliverables and clinical trial timelines.
• Responsible for design, development, programming and maintenance of clinical study databases for clinical trials.
• Develop and deploy case report forms; including automated edit checks and indications of critical variables using EDC / CTMS.
• Produce and maintain database queries using MSSQL and electronic data capture tools to assure quality interim and final reporting of clinical data.
• Maintain and support SQL Servers and data analytics platforms and processes.
• Coordinate and conduct database validation activities with key stakeholders.
• Create and maintain data management plans, operating procedures, and supporting files to ensure compliance with global regulatory bodies.
• Conduct data scrubbing and reporting activities.
• Collaborate cross-functionally to resolve or escalate data management issues, and ensure effective communication throughout all clinical trial phases
• Maintain clinical study hardware and software for use in the conduct of clinical studies
• Knowledge of FDA regulations and industry best practices (. GCP, 21 CFR Part 11, ISO 14155)
• Other duties as assigned.

Travelling Requirement : Occasional travel to study centers, professional conferences, and Advanced Bionics corporate events.

What you bring to the team :

Education

Bachelor’s Degree

Nice to Have

Post-baccalaureate degree

Further Education

Formal training in clinical data management systems

Nice to Have

Familiarity with Class III medical devices

Work Experience

2 plus years of experience in clinical data programming or clinical data management

Nice to Have

Familiarity with back end administration of electronic data capture systems

Personal Competencies

Solution-oriented mindset with an attention to detail

Nice to Have

Open to continuous improvement

Social Competencies

Exceptional spoken and written communication ability

Nice to Have

Highly collaborative

Professional Competencies

Project management expertise within the administration of EDC and CTMS platforms.

Nice to Have

Experience working in an FDA regulated studies for whole study lifecycle from study startup to closeout and CSR completion.

Language(s) / Level

English / Fluent

IT Skills

Experience with report development using MS-SQL, MS Access & any procedure or object-oriented programming languages

Nice to Have

Familiarity with eTMF systems

Our offer :

• Exciting and challenging work environment
• Comprehensive benefits package
• Training and development opportunities we believe every employee deserves a development plan. Come, learn, and grow with us!

Don't meet all the criteria? If you’re willing to go all in and learn we'd love to hear from you!

We love to work with great people and strongly believe that a diverse team makes us better. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed / religion, sex, sexual orientation, marital status, age, mental or physical disability.

We thank all applicants in advance; however only individuals selected for an interview will be contacted. All applications will be kept confidential.