Senior Manager, Clinical Compliance
General Scope and Summary
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.
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.
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.
Number of Openings:1
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All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.
Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.#LI-Remote