Research Compliance Case 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

Perform data entry alongside current data quality standards

At least 1 years’ experience in a legal, compliance or risk function within financial services

Ideally experience in one of the following disciplines: Prudential Risk, Regulatory Compliance, Information security, Data Privacy, Technology Risk

Gather regulatory information at the request of clients from a range of sources.

Input necessary regulatory information into the firm’s product, including citations and relevant extracts.

Monitor legal and regulatory developments of assigned regions and industries

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

Experience working with partner organizations to achieve compliance requirements

An equivalent combination of education and experience may be considered.

Experience with research compliance, preferably in an academic environment

Experience managing quality assurance and compliance with program standards

Benefits of working at Temple University include:

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