AD​/Director, Clinical Operations Compliance

Location: Northern

# AD/Director, Clinical Operations Compliance Apply
** Job#: 3051426
***
* Job Description:

** Associate Director/Director, Clinical Operations Compliance (Contract)
Our Cambridge based client is seeking a consultant to serve as the clinical operations compliance leader across a growing development portfolio. This individual will partner closely with Clinical Operations, Quality, Regulatory, Data Sciences, Pharmacovigilance, and Clinical Research teams to ensure inspection readiness, strengthen operational processes, and drive compliance excellence across clinical programs.

This is a highly visible leadership role responsible for establishing and maintaining Clinical Operations standards, overseeing SOP development and management, supporting vendor governance, and ensuring adherence to GCP, ICH, FDA, EMA, and other applicable regulatory requirements.

Key Responsibilities
* Lead Clinical Operations compliance initiatives, processes, and standards
* Drive SOP, work instruction, and TMF governance programs
* Ensure inspection readiness through oversight, training, and continuous improvement activities
* Partner cross-functionally to support quality and compliance objectives across clinical trials
* Provide compliance oversight for trial management, monitoring, vendor management, TMF, data operations, investigational product management, and study closeout activities
* Support issue escalation, CAPA development, and resolution management
* Contribute to global regulatory submissions and inspection preparation activities
* Serve as the internal subject matter expert for clinical compliance and regulatory requirements Qualifications
* Bachelor's degree in a scientific discipline; advanced degree preferred
* 10+ years of biotech, pharmaceutical, or CRO experience
* 8+ years of clinical operations experience
* Leadership experience managing and mentoring teams
* Demonstrated success supporting complex clinical development programs and regulatory inspections
* Deep understanding of GCP, ICH, FDA, EMA, and clinical trial compliance requirements
* Strong experience with SOP development, TMF management, vendor oversight, and inspection readiness
* Exceptional relationship-building, communication, and problem-solving skills

This opportunity is ideal for a compliance-focused clinical operations leader who enjoys building scalable processes, driving organizational excellence, and partnering across functions to support the successful execution of clinical development programs.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals.

We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENTTMStratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

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* Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package.

Our commitment to excellence is reflected in many awards, including Clearly Rateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
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