Clinical Research Compliance Manager Jobs

With direction and oversight from the management and executive levels, the Manager, R&D Compliance and Standards:

Manages CAPAs including those arising from deviations and incidents

3+ years’ experience in medical product research and development

Thorough knowledge of US Food and Drug Administration (FDA) and European regulations

Strong interpersonal, written and verbal communication skills

Assists in developing and maintaining quality systems and controlled documents

Use excellent time management skills and work on multiple projects on deadline.

Use strong writing skills to convey a professional tone with exceptional attention to grammar, syntax, and spelling.

Proficient knowledge of Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams), Box cloud storage, Zoom videoconferencing, and Adobe Acrobat.

Use of excellent communication and interpersonal skills.

Two or more years of experience as a paralegal, regulatory, compliance, research, or related field.

Ability to learn new software applications.

Demonstrated organizational skills and ability to pay close attention to detail.

Demonstrated critical thinking and analytical skills.

Demonstrated knowledge of database, word processing, and spreadsheet programs.

Title: Clinical Research Compliance Manager

Approximately five years of prior experience in a clinical research setting.

As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices