Remote Clinical Data & Quality Compliance Manager

Openkrill; United States; Remote; USD 101,000 - 146,000; Full time

Job summary

Resilience Care is seeking a dedicated QA/Regulatory Compliance professional to oversee GCP compliance across sponsored studies and partnerships. You will integrate data integrity with system qualification and collaborate with clinical, data, and vendor teams.

You will help keep studies inspection-ready, ensure data reliability, and embed compliance into daily workflows while coordinating with CROs and partners to uphold regulatory standards.

Qualifications

• Minimum five years of relevant experience in Clinical Data Management and GCP compliance within a pharmaceutical company or CRO.
• Experience with deviations, audits, inspections, or procedures.
• Experience with computerised system qualification.
• Familiarity with EDC systems such as Medidata Rave, Veeva or Oracle, and ePRO/eCOA solutions.
• Ability to translate regulatory requirements into practical controls.

Responsibilities

• Oversee GCP compliance and manage deviations and CAPAs.
• Maintain inspection readiness and support CRO oversight in line with ICH E6(R3).
• Qualify systems using CSV/CSQ approaches and apply ALCOA+ principles.
• Work with EDC systems and ePRO/eCOA solutions, translating requirements into practical controls.
• Communicate and train teams, and monitor regulatory developments.

Skills

GCP compliance

Quality management

Regulatory knowledge

Cross-functional collaboration

Communication in English

Education

Bachelor's degree in life sciences

Tools

Medidata Rave

Veeva

Oracle EDC

ePRO/eCOA

Job description

Resilience Care is seeking a dedicated QA/Regulatory Compliance professional to oversee GCP compliance across sponsored studies and partnerships. You will integrate data integrity with system qualification and collaborate with clinical, data, and vendor teams.

You will help keep studies inspection-ready, ensure data reliability, and embed compliance into daily workflows while coordinating with CROs and partners to uphold regulatory standards.