Sr. Manager, Clinical Compliance
- San Clemente, CA
The Sr. Manager, Clinical Compliance, based in San Clemente, CA will be responsible for developing, leading, implementing and conducting strategies and activities to assure Glaukos Clinical Research remains in compliance with applicable regulations and laws maintaining a constant state of audit readiness.
Internal clinical audits
• Develop an internal clinical audit program.
• Manage the execution of internal clinical audits for both Clinical Research and clinical site audits.
• Draft summary reports of internal clinical audits.
• Facilitate and lead cross-functional internal audit corrective actions seeing them through to completion.
External clinical inspections
• Facilitate the execution of external clinical inspection preparations.
• Facilitate the external inspection process to include back room staging and review of documents in real time and the provision of requested materials to inspectors.
• Generate summary reports of external inspections.
• Serve as the clinical lead on responses to any external inspection findings.
• Support investigator sites undergoing external inspections.
• Identify opportunities to improve processes.
• Assist in the continuous review of clinical research processes to drive and support in-house continuous improvement including streamlining processes and maintaining GCP compliance.
Standards and Regulations
• Develop an ongoing program to review external standards and regulations as related to clinical research globally.
• Conduct gap analyses of current standards to Glaukos procedures and processes.
• Lead, in conjunction with key stakeholders, updates to Glaukos clinical procedures and processes to remain within compliance with regulations and standards.
Clinical Standard Operating Procedures (SOP)
• Work with stakeholders to create clinical SOP's, work instructions, forms and templates as requested.
• Develop a plan for continuing review of clinical SOP's, work instructions, forms and templates. In addition, work with stakeholders to create revisions as required.
• Implement, lead and manage SOP deviation processes with the Clinical teams.
• Implement and support cross-functional quality and risk management activities.
Systems validations and UAT management
• Working with key stakeholders, develop a systems validation and User Acceptance Testing procedure to include new software systems and updates to existing software systems. For systems validations and UAT that are managed by a corporate function, provide assistance as needed.
• With assistance from key stakeholders, generate software systems validation and UAT reports, or if validation or UAT activities are performed by corporate, assure proper documentation is generated and is on file to satisfy inspection and audit needs.
• Minimum of 5 years of clinical research experience, preferably in both device and pharmaceutical.
• Preferred 2 or more years' experience in clinical quality
Knowledge, Skills, and Abilities:
• Knowledge of clinical study designs and protocols
• Experience in addressing and drafting responses to regulatory agencies.
• Thorough understanding of the CFR, FDA/ICH guidelines, GxP and cGMP as they pertain to clinical research.
• Ability to understand and interpret complex scientific and regulatory issues.
• Willingness to be part of a fast-paced organization and possessing a hands-on, roll-up-your-sleeves mentality.
• Team player and adaptable, with strong technical and problem-solving skills.
• Excellent interpersonal skills with the ability to influence without authority.
• Excellent written and verbal communication skills.
• Excellent computer skills (Microsoft Office-Word, Excel, PowerPoint).
• A Bachelor's Degree in a scientific discipline from an accredited university is required.
• An advanced degree is preferred.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world's leading causes of blindness.
The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression.
The company's second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.
In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol “GKOS”. The company was founded in 1998 and is based in San Clemente, California.
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