Director Clinical Operations Compliance

Apex Systems; United States; On-site; USD 160,000 - 200,000; Full time

Job summary

Apex Systems is seeking an Associate Director/Director, Clinical Operations Compliance (Contract) to lead compliance across a growing development portfolio. This senior role partners with Clinical Operations, Quality, Regulatory, Data Sciences, Pharmacovigilance, and Clinical Research to strengthen processes and support inspection readiness across programs.

The role includes establishing and maintaining Clinical Operations standards, SOP development, vendor governance, and TMF programs, with

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Experience in biotech, pharmaceutical, or CRO environments.
• Clinical operations experience with leadership in managing teams.

Responsibilities

• Lead clinical operations compliance across a growing development portfolio.
• Establish standards, SOPs, TMF programs, and vendor governance.
• Ensure adherence to GCP/ICH/FDA/EMA and inspection readiness.
• Provide escalation, CAPA, and remediation for trial management and study closeout.

Job description

The client is seeking an Associate Director/Director, Clinical Operations Compliance (Contract) to lead clinical operations compliance across a growing development portfolio. In this highly visible leadership role, the selected individual will partner closely with Clinical Operations, Quality, Regulatory, Data Sciences, Pharmacovigilance, and Clinical Research to strengthen operational processes and support inspection readiness across clinical programs.

The role will establish and maintain Clinical Operations standards, oversee SOP development and management, support vendor governance, and ensure adherence to applicable regulatory requirements, including GCP and relevant international and regional guidance. Responsibilities include driving clinical operations compliance initiatives; implementing and governing SOPs, work instructions, and TMF-related programs; providing compliance oversight for areas such as trial management, monitoring, vendor management, TMF, data operations, investigational product management, and study closeout activities; and managing issue escalation, CAPA development, and resolution activities.

The position will also contribute to global regulatory submissions and inspection preparation, and serve as an internal subject matter expert for clinical compliance and regulatory requirements. Qualifications include a bachelor’s degree in a scientific discipline, with an advanced degree preferred; demonstrated experience in biotech, pharmaceutical, or CRO environments; clinical operations experience; and leadership experience managing and mentoring teams. The ideal candidate will have strong knowledge of GCP/ICH/FDA/EMA and clinical trial compliance, proven experience with SOP development, TMF management, vendor oversight, and inspection readiness, and excellent communication and problem-solving skills.