Associate Director/Sr. Manager, Clinical Compliance Specialist

Bostonfull time

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Remote

senior

$190k–$210k

H1B: no

Celeatherapeutics Associate Director/Sr. Manager, Clinical Compliance Specialist at Celea Therapeutics ensures compliance with clinical regulations and GCP across clinical development programs. The role supports inspection readiness, SOP development, and training oversight for Phase 3 clinical studies.

Responsibilities

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 the implementation of corrective and preventive actions (CAPAs) and continuous compliance improvement initiatives.
Develop, maintain, and periodically review and update clinical SOPs, work instructions, templates, and guidance documents to ensure alignment with current regulations, industry standards, and organizational needs.
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.

Qualification

Bachelor's degree in Life SciencesAdvanced degree preferredExperience working in pharmaceuticalWhy Join Celea Therapeutics

Required

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

Preferred

Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or equivalent certification.
Experience supporting regulatory inspections (FDA, EMA, MHRA, PMDA, or other health authorities).
Experience with electronic quality management systems (eQMS), document management systems, and clinical trial systems.
Knowledge of risk-based quality management (RBQM) principles.
Experience working with global clinical trials and outsourced service providers.
Why Join Celea Therapeutics
Play a pivotal role in advancing life-changing therapies for patients with devastating lung diseases.
Shape the foundation of a Phase 3 biotech poised for significant growth.

Benefits

Equity/RSU

Company

Celeatherapeutics

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Source: greenhouse

Active within the past hour

Remote-friendly

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