Senior Manager, Clinical Compliance

Full Time Remote in United States Quality Manager Compliance Apply for this Job Sage Therapeutics is seeking a creative, resourceful, and collaborative Clinical Compliance professional to contribute to a developing role within Clinical Operations and Development. The Senior Manager, Clinical Compliance collaborates with Clinical Operations, R&D Quality, and other cross-functional departments to provide ICH/GCP guidance and direction related to clinical trial conduct, oversight, and risk management as prescribed by regulatory guidance and Sage standard operating procedures.

The Senior Manager, Clinical Compliance will support Clinical Operations in the management and maintenance of clinical quality management systems associated with standard operating procedures, process improvement, training, and risk management. This key role will also support ongoing inspection readiness by completing Clinical Operations performance health checks, supporting the development and review of inspection readiness tools, and participating in regulatory inspection preparation activities.

Roles and Responsibilities

• Provide ICH/GCP clinical compliance consultation and support to Sage Clinical Operations and their stakeholders. Maintain current knowledge related to ICH/GCP guidelines and regulations and Sage standard operating procedures.
• Collaborate and develop strong relationships with personnel from Clinical Operations, Quality Assurance, and other Sage stakeholders to facilitate and support process improvement, risk management, and inspection readiness activities.
• Lead the development and review of written standard operating procedures, forms, and templates to meet the changing needs of the organization.
• Facilitate and support inspection readiness activities in Clinical Operations. Complete Performance Health checks and support mitigation actions through the development and revision of new tools and process improvement.
• Provide support during and following health authority inspections and internal audits.
• Serve as the Clinical Compliance representative for selected clinical study teams. Apply ICH/GCP guidance and clinical compliance knowledge to varying stages of clinical research, including risk identification/management, investigation/CAPA activities, and protocol deviation assessment.
• Identify and escalate significant quality and compliance risks to leadership within Clinical Operations and Development, Quality Assurance, and Corporate Compliance. Participate in investigation and mitigation measures.
• Experience, Education and Specialized Knowledge and Skills
• Must thrive working in a fast-paced, innovative environment while remaining approachable, flexible, proactive, resourceful, and efficient. Must have effective interpersonal skills and the ability to work cross-functionally to develop and promote new initiatives and process improvement. Must be detailed oriented and capable of analyzing and presenting data trends. Possesses the ability to translate complex processes and into clearly and succinctly written procedures, forms, and inspection readiness tools.

Basic Qualifications

• BS degree.
• 5+ years of pharmaceutical or biotechnology industry experience, with 2+ years of experience working in a quality assurance or clinical compliance position supporting Clinical Operations; must have 3+ years of experience working in Clinical Operations supporting the management of clinical trials.

Preferred Qualifications

• Prior experience writing standard operating procedures, analyzing complex processes, and participating in inspection readiness activities required.
• Experience with the interpretation and application of ICH/GCP expectations and standards to varying phases of clinical studies required.
• 7-9 years of pharmaceutical or biotechnology industry experience, with 2+ years of experience working in a quality assurance or clinical compliance position supporting Clinical Operations; must have 3+ years of experience working in Clinical Operations supporting the management of clinical trials.
• Strong, enthusiastic, and collaborative team member that prioritizes positive customer service and is solution-oriented.
• Possesses strong written and verbal communication skills.
• Organized, analytical, and attentive to detail.
• Proactive and self-driven to achieve on-time personal goals as well as to help others achieve desired outcomes and results.
• Ability to work individually and within a multi-disciplinary team.
• Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
• Excitement about the vision and mission of Sage.

Benefits and Compensation

• The base salary hiring range for this position is $125,606 - $172,709.*
• The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
• This position is eligible to participate in the Company’s annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
• To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide.

*Base salary ranges are periodically reviewed and subject to change.

Job ID: R002055