Supported Studies Manager

Supported Studies Manager, Irvine, CA

Responsibilities:

• Provide oversight and management of the Investigator-Initiated Studies (IIS) program within the Clinical Research Department.
• Lead study management activities, including intake and initial review of IIS proposals (via the Masimo brief proposal form), tracking IIS through their lifecycle, correspondence and communication with applicants, management of Masimo Brief Proposal Committee, follow-up and manuscript review as appropriate, and dissemination of appropriate information within Masimo to identify, analyze, and act on research information.
• Conduct all activities in accordance with government regulations (FDA, ISO 14155, MDD and International), Good Clinical Practices (GCP) and department standard procedures.
• Understand theory of operation of Masimo products and parameters, as well as clinical utility of Masimo's technology.
• Interact directly with external Principal Investigators, research sites, co-operative groups and public or private sector intergroups and networks in the U.S. or worldwide to facilitate the Medical review process and execution of (IIS) and to ensure compliance with Masimo standard procedures and global and local regulations.
• Stay current with relevant medical literature in support of clinical use of Masimo products.
• Stay abreast of applicable governmental compliance laws and industry standards for IIS.
• Manage PI correspondence and study documentation through the entire lifecycle of IIS studies.
• Manage and facilitate meetings of the Masimo Brief Proposal Committee for IIS review.
• Ensure appropriate and timely follow-up of action items and decisions.
• Use knowledge and understanding to evaluate IIS proposals, summarize them and contribute to IIS review process.
• Retrieve and manage scientific references, and understand basic scientific content, experimental design, and analytical approaches used.
• Apply advanced understanding of scientific goals, principles of clinical study design and research methodology to assigned research projects in alignment with departmental objectives, creating proposals, protocols, plans, and strategies, etc.
• Act as clinical expert and liaison to provide investigators with Masimo product and IIS process information.
• Work effectively in team, successfully interacting with internal stakeholders (R&D, Marketing, Manufacturing, Regulatory, etc.) and external stakeholders (Customers, Investigators, Coordinators, Biomed Dept., patients, etc.).
• Represent Masimo in major scientific congresses to gather updates from investigators on ongoing research, discuss plans and collect data.
• Collaborate with investigators on publication plans, abstract presentations and scientific posters.
• Conduct moderate to advance data analysis using spreadsheet and statistical programs, and organize reports of data in simple clear fashion with appropriate tables, charts and graphs.
• Order, pack, ship and track equipment for IIS studies.
• Retrieve equipment at the end of the study and disposition them appropriately.

Qualifications: THIS POSITION REQUIRES A BACHELOR'S DEGREE (OR FOREIGN EQUIVALENT) IN NURSING, OR CLOSELY RELATED HEALTH FIELD, PLUS 2 YEARS OF WORK EXPERIENCE IN THE JOB OFFERED OR CLOSELY RELATED OCCUPATION.

Special Requirements:

• Experience in clinical, medical or biological research, with strong emphasis on experimental design and analytical and statistical techniques.
• Working knowledge of ICH-E6 Good Clinical Practice and ISO-14155 Clinical Investigation of Medical Devices for Human Subjects.
• Working knowledge of Federal and International medical device regulations.
• Experience collaborating with multi-disciplinary teams: engineering (study designs, data sharing and decryption, optimal product performance conditions), regulatory affairs (ensuring regulatory compliance with domestic, international and local regulations), legal (initiating and facilitating legal contracts and amendments), sales (local clinical specialists utilized for training, complex product setup), and technical services (troubleshooting technical issues, device disposition).
• Working knowledge of scientific study designs (including RCT), statistical outcomes measurements, population and sampling methodologies, and data management to critically evaluate and assess research proposals for scientific rigor.
• Experience in presenting and writing complex information and processes to both internal and external stakeholders, as well as experience preparing concise, detailed, written communication.

Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge maybe gained through employment experience or education. Such expertise/knowledge cannot be "quantified" by "time."

Up to 15% travel required locally, domestically and internationally.

Salary: $154,336 - $158,000 per year

Masimo Corporation is an equal opportunity employer.

How to apply: Qualified applicants please send resume to: Delora Sandoval: dsandoval@masimo.com. Must reference JOB CODE#: PMB-25 when applying.

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