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

Under the direction of the Senior Clinical Program Manager, the Clinical Research Compliance Manager is responsible for managing all operational aspects for implementation of clinical trial activities from study start-up to database lock, ensuring compliance to applicable regulations, GCP, and relevant standard operating procedures.

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

• 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.

• 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 and/or perform site monitoring (qualification, initiation, routine monitoring and close out visits).Manage monitoring schedule and monitoring resources to ensure studies are monitored in accordance to SOPs and monitoring plans.

• 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.

• 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.

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

• Provide support to sites to prepare for clinical audits and to respond to audit findings conducted by Masimo QA and external regulatory agencies.

• Contribute to clinical study design, proposals, protocols, etc., understanding scientific content, experimental design, and analytical approaches used.

• 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.

• Responsible for planning and resource leveling for all sponsored clinical studies.

• Provide support to Masimo RA for submissions and strategy.

• Identify institutions, sites and investigators to collaborate on clinical research initiatives and studies.

• Interface with KOLs and Investigators.

• Work and communicate effectively with investigator, staff and patients in professional, sensitive and mature manner.

Minimum Qualifications

• Experience with medical devices preferred.

• Experienced with Good Clinical Practice (GCP) in conduct of clinical studies.

• 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.

• Ability to independently set and manage multiple priorities.

• 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

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

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

• Clinical Research Associate certification.

Education

BA/BS 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 25-50% 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 Director, Clinical Research.

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

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