Sr Manager, Clinical Research Compliance

For over thirty years, Masimo has been expanding the boundaries of noninvasive monitoring to improve patient outcomes and reduce the cost of care. Today, Masimo delivers a portfolio of hospital-trusted monitoring solutions to help increase patient safety, health, and wellness in the hospital and at home. When you join our team, you'll be part of a culture that's driven by passion, challenging the status quo, and making an impact in the lives of others.

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Job Summary:

The Senior Clinical Research Compliance Manager is responsible for managing the Clinical Research Compliance group under the direction of the Chief Medical Officer, overseeing Clinical Compliance activities for all aspects of Masimo's Clinical Research Program. Areas may consist of clinical research studies, Sponsored/Investigator Initiated (IIS)/Real World Evidence (RWE), that provide valid data sets for product development and regulatory submission with a goal to generate significant published studies that demonstrate the superior performance and cost effectiveness of Masimo products. The Senior Clinical Research Compliance Manager is responsible for managing all operational aspects for the implementation of clinical trial activities from study start-up to database lock, ensuring compliance to applicable regulations, GCP, and relevant standard operating procedures (SOP).

All activities will be conducted in accordance with Government Regulations (FDA, MDD and International), Good Clinical Practices (GCP) and Department Operating Procedures (DOP).

Duties & Responsibilities:

• Primarily responsible for managing the Clinical Research Compliance Program at Masimo, to ensure studies are compliant with all applicable international, federal and local regulations.

• Implement and support cross-functional quality and risk management activities

• Oversee the planning, implementation and close-out of clinical studies in support of project timelines and market release goals to ensure compliance with regulations and GCP. Track and collaborate with study managers to ensure clinicaltrials.gov postings are generated, maintained, updated and posted, as needed.

• Provide training and oversight to staff maintaining clinical trial master files to ensure their compliance with relevant regulatory and GCP quality standards and consistency with Masimo SOPs

• Oversee site monitoring activities (qualification, initiation, routine monitoring and close out visits). Manage monitoring schedules and monitoring resources to ensure studies are monitored in accordance to SOPs and monitoring plans.

• Assist in the hosting of inspections and audits; creating responses to audit findings; tracking progress to ensure resolution; and identifying lessons learned

• Develop a program to review external standards and regulations related to clinical research globally

• Identify potential risks and resolve issues relating to clinical research compliance

• Develop and implement process improvement initiatives to strengthen Masimo clinical research study conduct and compliance.

• Develop company strategy for continued review of clinical SOP's, work instructions, forms and templates

• Implement and support cross-functional quality and risk management activities

• Conduct gap analyses of current standards to Masimo SQPs/SOPs and lead, in conjunction with key stakeholders, updates to Masimo's Clinical processes.

• Facilitate and lead cross-functional internal audit corrective actions

• Provide input and support to maintain appropriate documentation of adverse events, device deficiencies, and protocol deviations, and collaborating in submission of MedWatch reports to FDA for events arising from clinical research activities

• Provide support to Masimo QA during GCP inspections conducted by Masimo-contracted third parties and external regulatory agencies.

• Provide support to teams in preparation for clinical audits and to respond to audit findings conducted by Masimo QA and external regulatory agencies.

• Provide input and review study related materials such as clinical protocols, monitoring plans, data management plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage and accuracy across all projects.

• Provide support to Masimo RA for submissions and strategy.

• Provide consultation and direction on clinical regulations, guidance and expectations to business colleagues

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• Experience with medical devices preferred.

• Expert knowledge of applicable regulations and standards as they relate to clinical trial conduct.

• Excellent written and verbal communication skills essential.

• Must be capable of interacting with all levels of management, coworkers, investigators and subjects

• Proficiency with Microsoft Office, computer data acquisition, data analysis, graphing and plotting results and report writing.

• Strong influencing skills, with the ability to work collaboratively and cross functionally, within a constantly evolving fast-paced startup environment

• Ability to drive and manage change with a positive approach

• Demonstrates advanced judgment and decision making ability in the execution / oversight of clinical studies.

• Ability to travel to data collection sites, local and domestic.

• Proven track record and experience in Clinical Research.

Preferred Qualifications:

• 8+ years of clinical research experience, preferably US and OUS.

• Preferred 3 or more years' experience in clinical quality.

• Excellent knowledge of FDA and ISO Good Clinical Practice (GCP) Regulations, Medical Device Directive, Canadian Medical Device Regulation, and other international requirements.

• Experience leading, developing and/or implementing Inspection Readiness Programs and associated activities

• Experience leading mock FDA audits.

• Knowledge of clinical study designs and protocols.

• Experience in addressing and drafting responses to regulatory agencies.

• Understand and interpret complex scientific and regulatory issues.

• Strong clinical background preferred. (e.g., respiratory therapy, nursing, pharmacology, physiology).

• Clinical Research Associate certification.

Education:

Bachelors degree required or equivalent years of experience required, preferably in life sciences. Advance degree in life sciences preferred.

Compensation: Base Range $140,000- $175,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Ability to physically pack, ship, move, unpack, set up and execute equipment for study at clinical site, repack and ship back to Masimo. Approximately 20% travel, both domestic and international. Travel requirement is subject to change based on business needs. Must have the ability to operate a motor vehicle and maintain a valid Driver's license.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Reporting Relationships:

This job reports to the Chief Medical Officer (CMO).

Masimo is an Equal Employment Opportunity Commission / Affirmative Action employer. We encourage Minorities, Females, Disabled and Veterans to apply

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