Remote/Hybrid Associate Director, Clinical Compliance

Celea Therapeutics; Boston; Hybride; PHP 12 102 000 - 13 376 000; Plein temps

Avantages offerts par ce poste

Equity package

Competitive compensation

Résumé du poste

Celea Therapeutics is seeking an Associate Director/Sr. Manager, Clinical Compliance Specialist to lead and maintain regulatory compliance across Phase 3 clinical programs, ensuring adherence to GCP, ICH, FDA and EMA standards.

The role partners with Clinical Operations, QA, Regulatory Affairs and study teams to drive inspection readiness and continuous quality improvements. This position offers remote or hybrid work options (Boston area) and will oversee SOP development, training, vendor and

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.
• Understanding of site management, TMF requirements, and vendor oversight.
• Familiarity with audit and inspection activities.
• Strong training and presentation capabilities.

Responsabilités

• Ensure 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 the implementation of CAPAs and continuous compliance improvement initiatives.
• 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.

Connaissances

Organizational skills

Documentation

Training

Presentation skills

Cross-functional collaboration

Formation

Bachelor's degree in Life Sciences

Advanced degree preferred

Outils

eQMS

Clinical trial systems

Description du poste

Celea Therapeutics is seeking an Associate Director/Sr. Manager, Clinical Compliance Specialist to lead and maintain regulatory compliance across Phase 3 clinical programs, ensuring adherence to GCP, ICH, FDA and EMA standards.

The role partners with Clinical Operations, QA, Regulatory Affairs and study teams to drive inspection readiness and continuous quality improvements. This position offers remote or hybrid work options (Boston area) and will oversee SOP development, training, vendor and