Data Integrity Project Manager

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Responsibilities

• Audit pharma, medical device, clinical, and software development organizations for compliance with health authority regulations applicable to computer system and data integrity
• Conduct gap assessments and provide remediation guidance for compliance with health authority regulations applicable to computer system and data integrity.
• Authoring policies, procedures, and work instructions compliance with health authority regulations applicable to computer system and data integrity
• Provide clients with advice and guidance on computer system validation and data integrity compliance approaches. Manage teams of internal resources in executing these strategies.
• Assist in developing and maintaining internal procedures and tools for delivery of CSV and data integrity services.
• Develop and deliver original CSV content on current topics impacting the area of Computer System Validation and electronic data integrity. Examples include blogs, training materials, webinars.

Required skills and experience

• Minimum 10 years in Pharma/Med Device industry
• Minimum 3+ years Project Management experience.
• Experience in the validation of all computer system categories: automation control, laboratory systems, quality management systems, ERPs, clinical trial and pharmacovigilance applications.
• Experience managing internal personnel.

**10 month contract opportunity onsite at facility in New York.