Senior Clinical Programming Lead – Medidata & EDC (Hybrid)

Regulatory Jobs; Irvine (CA); Hybrid; USD 132.000 - 186.000; Vollzeit

Zusammenfassung

Edwards is seeking a seasoned Clinical Programmer to join our Clinical Affairs team in California. You will lead the development of clinical databases, data validation checks, and trial reporting, collaborating with investigators, medical professionals, patient advocates, and regulatory authorities to advance our innovative therapies.

The role requires a Bachelor's degree and 6+ years in clinical research or related fields, with extensive Medidata/EDC experience.

Qualifikationen

• Bachelor's Degree and minimum 6 years in clinical research or related field.
• Extensive experience with EDC systems; Medidata programming experience.
• Master's Degree with 5+ years or PhD with 2+ years preferred.
• Expert knowledge in creating new Medidata custom functions in C# or SQL.

Aufgaben

• Provide clinical programming in data validation checks and trial reporting in collaboration with key stakeholders.
• Lead cross functional teams in design and delivery of complex functional modules and provide clinical programming expertise regarding trials, protocols, and CRFs.
• Lead the development of specifications for systems and/or processes, system upgrades/enhancements and integration; engage IT to deliver higher level support.
• Develop and present high level technical training to end-users, including guidance to junior Clinical Programmers.
• Identify resource needs for database implementation and evaluate external resources/vendors.
• Manage daily service providers' activities for outsourced systems and services used in clinical trials.
• Participate in the creation and revision of SOPs, work instructions, workflow, forms, and templates to ensure compliance.

Kenntnisse

Clinical programming

Data management

Project management

Communication skills

Presentation skills

Interpersonal relationships

Ausbildung

Bachelor's Degree

Master's Degree

PhD

Tools

Medidata

SQL

Microsoft Excel

CDM systems

Jobbeschreibung

Edwards is seeking a seasoned Clinical Programmer to join our Clinical Affairs team in California. You will lead the development of clinical databases, data validation checks, and trial reporting, collaborating with investigators, medical professionals, patient advocates, and regulatory authorities to advance our innovative therapies.

The role requires a Bachelor's degree and 6+ years in clinical research or related fields, with extensive Medidata/EDC experience.