Clinical Site Quality and Compliance Lead - Remote / Telecommute

Job Title: Clinical Site Quality and Compliance Lead - Remote / Telecommute

Job Location: Ridgefield, CT

Job Type: Contract

Pay Range: $93.00hr - $98.00hr

Job Overview:

The Site Quality and Compliance Lead plays a pivotal role in driving quality and regulatory compliance across clinical trial operations. This position oversees Phase I-IV national and international trials, supports inspection readiness, and develops tailored training programs for Clinical Development Operations.

Responsibilities:

• The Site Quality and Compliance Lead is fundamental to driving quality and compliance in the planning, preparation, and conduct, including monitoring, of clinical programs for Phase I-IV national and international trials, Expanded Access Programs, Registries, and Survey trials across Clinical Development Operations (CDO).
• The lead plays a critical role in developing and delivering CDO training programs effectively.
• Responsible for the implementation of quality activities and inspection readiness. As directed by the Team Lead, participates in and contributes to global functional quality network initiatives.
• Ensures quality activities are conducted in compliance with governmental regulations (i.e., FDA/ICH/Google Cloud Platform), company SOPs, local working instructions, and business ethics while adhering to financial targets.
• Develops and delivers just-in-time training initiatives to the CDO organization.
• Plans and coordinates assigned training initiatives to ensure timely delivery of high-quality project outcomes within set timelines and financial targets.
• Supports curriculum development by analyzing course materials and training methods across CDO roles.
• Works in collaboration with cross-functional partners in CDO, Legal, and other Medical/Regulatory Affairs functions to facilitate the communication necessary to drive quality in the planning, preparation, and conduct of clinical programs.
• Works in collaboration with Quality Medicine and other cross-functional partners to assist in activities addressing findings related to sponsor inspections and internal audits focused on CDO.
• Proactively identifies, supports, and assists in the development and implementation of CDO quality activities and inspection readiness, including performing quality process reviews.
• Acts as the primary point of contact for CDO non-compliances for triage to Quality Medicine partners.
• Maintains a working partnership with Quality Medicine, cross-functional partners across CDO, Legal, and other Medical/Regulatory Affairs functions, executing coordinated programs based on common goals and objectives.
• Participates in site non-compliance meetings to assist trial teams in the development of Corrective and Preventive Action (CAPA) plans, serving as a CAPA champion as required.
• Executes the reporting of quality metrics to assess quality trends, individual performance needs, and compliance issues.
• Identifies potential areas of risk and collaborates with CDO team members to establish risk mitigation strategies.
• Supports the execution of onboarding to CDO and Medicine, as well as process improvement initiatives and training programs to address quality or performance issues.
• Ensures trends and lessons learned are disseminated to the CDO organization on a routine cadence.
• Performs all business in accordance with all regulations (EEO, FDA, ICH, DEA, OSHA, PDMA, PhMA, etc.) and company policies and procedures.
• Maintains current knowledge of and adherence to government regulations (e.g., FDA, ICH, Google Cloud Platform) and company SOPs, local working instructions, and role-specific training.

Education:

• Bachelor s Degree (highly preferred in life sciences).

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities