Job Details

TruLab, Inc. is an RTP-based mobile technology company that provides biological sample tracking and management solutions for clinical trials. TruLab's mission is to eliminate loss of samples provided for research by patients. The TruLab solution empowers drug developers to track biosamples from the point of collection in real-time and ensure protocol compliance and data integrity in clinical studies.

Position Overview :

The Director of Compliance position, based in RTP, NC, is a full-time role integral to our company's growth. This individual will be a key driver in expanding our operations, with a broad and dynamic range of responsibilities. Key duties include managing vendor quality assessments and audits, overseeing company policies, SOPs, and related documentation, conducting internal audits, administering internal training, and reviewing legal agreements, particularly those concerning data privacy. Additionally, the role ensures compliance with data privacy and protection laws, such as GDPR. The Director of Compliance will closely collaborate with the TruLab Quality and Executive Teams and report directly to Executive Leadership.

We are looking for candidates who can identify compliance and legal issues, give them due consideration within the context of the company's broader business priorities, and propose appropriate solutions. Candidates should be detail-oriented, proactive, and thrive in a fast-paced, dynamic and non-hierarchical environment. Ideal candidates will learn quickly, execute with excellence, and possess very strong organization and communication skills.

What You'll Do :

• Work directly with clients and prospective clients on their vendor quality assessments and audits of TruLab
• Administer IT security and data protection training for internal staff, archive documents as needed, and recommend additional training to keep staff informed on needed topics
• Update TruLab's internal policies and SOPs on a regular basis, and create new policies and SOPs as required
• Identify elements needed for the continued improvement of TruLab's Quality Management System and compliance efforts, and institute those items and practices
• Perform internal audits and other assessments of compliance with policies and SOPs
• Review, draft and negotiate commercial agreements, such as SaaS agreements, service level agreements, master service agreements, SOWs and NDAs, and billing documents, as appropriate

What You'll Need :

• Familiarity with 21 CFR Part 11 and GxP regulations
• A minimum of three (3) years of relevant experience in a compliance-related or legal field
• Knowledge and understanding of contract, commercial, and corporate law
• Knowledge and understanding of the transactions, processes and legal issues associated with SaaS businesses. Knowledge and understanding of the clinical research / clinical trials industry and of the regulations relating thereto are highly desirable
• A strong attention to detail
• Ability to communicate effectively in and across teams; must possess strong verbal, written, and interpersonal communication skills

What You'll Get :

• Exposure to all aspects of building a growth technology company
• Close contact with TruLab's experienced leadership team
• An opportunity to have a voice in major decisions
• To be part of the team revolutionizing sample tracking and advancing clinical research
• Opportunities to advance and develop as the company grows

This is a mid-level position. For more information, please contact Nicole Wolfgang at ...@trulab.com.