Remote Senior Clinical Compliance Lead

Celea Therapeutics; United States; Híbrido; USD 190.000 - 210.000; Jornada completa

Descripción de la vacante

Celea Therapeutics is seeking an experienced, strategic Associate Director/Sr. Manager, Clinical Compliance Specialist to ensure adherence to GCP, regulatory requirements, SOPs, and industry standards.

You will collaborate with Clinical Operations, QA, Regulatory Affairs, and study teams to promote inspection readiness and process excellence across programs. In the near term, you will support Phase 3 studies focusing on inspection readiness, SOP development, and training oversight, contributing

Formación

• Bachelor’s degree in Life Sciences, Nursing, Health Sciences, Pharmacy, or related field.
• Advanced degree preferred.
• 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 ability to translate requirements into practical operational guidance.
• Experience supporting SOP development and quality system processes.
• Working knowledge of clinical trial lifecycle and site management, monitoring, TMF requirements, and vendor oversight.
• Familiarity with audit and inspection activities.
• Strong organizational and documentation skills.
• Strong training and presentation capabilities.

Responsabilidades

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

Conocimientos

Organizational skills

Documentation skills

Training & presentation

Audit & inspection

Regulatory knowledge

Quality systems

Cross-functional collaboration

Educación

Life Sciences

Nursing

Health Sciences

Pharmacy

Advanced degree

Herramientas

eQMS

Document mgmt systems

Clinical trial systems

Descripción del empleo

Celea Therapeutics is seeking an experienced, strategic Associate Director/Sr. Manager, Clinical Compliance Specialist to ensure adherence to GCP, regulatory requirements, SOPs, and industry standards.

You will collaborate with Clinical Operations, QA, Regulatory Affairs, and study teams to promote inspection readiness and process excellence across programs. In the near term, you will support Phase 3 studies focusing on inspection readiness, SOP development, and training oversight, contributing