Senior Clinical Compliance Director — Remote

Celea Therapeutics; Boston (MA); Hybrid; USD 190,000 - 210,000; Full time

Benefits offered by this job

Equity package

Competitive compensation

Remote or hybrid work options

Job summary

Celea Therapeutics is seeking an experienced, strategic, and hands-on Associate Director/Sr. Manager, Clinical Compliance Specialist to ensure adherence to GCP, SOPs, and regulatory standards across clinical programs.

This role partners with Clinical Operations, QA, Regulatory Affairs, and study teams to maintain inspection readiness and drive process excellence. In the near term, focus will be on Phase 3 readiness, SOP development, and training oversight, guiding Celea through its next growth

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Health Sciences, Pharmacy, or related field required.
• 3-7 years of experience in clinical research, clinical operations, quality assurance, or clinical compliance.
• Experience working in pharmaceutical, biotechnology, medical device, or CRO environments.
• Knowledge of global clinical trial regulations and compliance requirements and ability to translate requirements into practical operational guidance.
• Experience supporting SOP development and quality system processes.
• Working knowledge of clinical trial lifecycle and study execution and understanding of site management, monitoring, TMF requirements, and vendor oversight.
• Familiarity with audit and inspection activities.
• Strong organizational and documentation skills.
• Strong training and presentation capabilities.

Responsibilities

• Ensure GCP, ICH, FDA, EMA, and other applicable regulations across clinical development programs and serve as a compliance resource to Clinical Operations teams.
• Monitor and assess clinical trial processes, identifying compliance risks, deviations, and inspection readiness concerns.
• Assist study teams in identifying and resolving operational compliance issues and support CAPAs and continuous improvement initiatives.
• Develop, maintain, and update clinical SOPs, work instructions, templates, and guidance documents.
• Partner with cross-functional teams to enhance quality systems and track SOP training completion.
• Support internal audits, vendor audits, and regulatory inspections.
• Support quality management system activities and continuous improvement initiatives.

Skills

GCP compliance

Regulatory knowledge

Audit readiness

Documentation skills

Training skills

Education

Bachelor's degree in Life Sciences, Nursing, Health Sciences, Pharmacy, or related field

Advanced degree preferred

Tools

eQMS

Document management systems

Clinical trial systems

TMF systems

Job description

Celea Therapeutics is seeking an experienced, strategic, and hands-on Associate Director/Sr. Manager, Clinical Compliance Specialist to ensure adherence to GCP, SOPs, and regulatory standards across clinical programs.

This role partners with Clinical Operations, QA, Regulatory Affairs, and study teams to maintain inspection readiness and drive process excellence. In the near term, focus will be on Phase 3 readiness, SOP development, and training oversight, guiding Celea through its next growth