Principal Clinical Research Scientist

JOB DESCRIPTION

The Principal Clinical Research Scientist demonstrates significant scientific judgment in clinical research study protocol design using experience and expertise in research and literature review. This position manages complex clinical research projects to support R&D efforts, regulatory filings, or marketing initiatives within Masimo Corporation. This position designs clinical study protocols and analyzes scientific data to develop clinical investigation plans, reports, and publications for both pre-market and post-market clinical studies. This position must also ensure that all activities are conducted in accordance with regulatory agencies (FDA, EU MDR and International), Good Clinical Practices (GCP) and company Standard Operating Procedures (SOPs).

Duties & Responsibilities

• Demonstrates strong understanding of theory of operation and clinical performance of Masimo products and parameters, product development pipeline, therapeutic space, and business needs;

• Leads the design of clinical study protocols for pre- and post-market clinical studies at Masimo;

• Utilizes advanced understanding of scientific goals and applies principles of clinical study design and research methodology to assigned research projects in alignment with company objectives;

• Collaborates with investigators and research teams to gain input into study design and evaluate study feasibility;

• Develops clinical trial documents and supports regulatory submissions with minimal supervision, including study protocols, clinical investigation plans, and clinical study reports;

• Writes clear, succinct and detailed clinical study documents, citing appropriate literature, where applicable, and manages interactions with principal investigators;

• Retrieves and manages scientific references, and understands scientific content, experimental design, and analytical approaches used;

• Works effectively in teams, successfully interacting with internal stakeholders (R&D, Marketing, Manufacturing, Regulatory, etc.) and external stakeholders (Customers, Investigators, Coordinators, CROs, etc.);

• Works as a skilled project manager who plans, implements and concludes complex clinical studies in support of major project timelines and market release goals;

• Reviews and critically analyzes statistical analysis plans;

• Conducts moderate to advanced data analysis using spreadsheet and statistical programs; organizes data clearly with appropriate tables, charts and graphs;

• Suggests improvement to departmental procedures for improved compliance to GCP;

• Ensures applicable trial registration from study initiation through posting of results and support publications as needed; (e.g., on www.clinicaltrials.gov)

• Operates Masimo products and data acquisition systems for data collection at sites, as needed;

• Manages all monitoring functions to ensure compliance to protocol, as needed;

• Stays current with relevant medical literature in support of clinical use of Masimo products, and can assist colleagues from other teams with literature reviews and interpretations for product planning, development, and marketing;

• Acts a mentor, provides education and shares expertise to aid in career development of junior team members;

• Ability to travel up to 10% of time, locally, domestically and internationally;

• Works independently with limited supervision, depending on project/task complexity;

• Performs special projects as requested.

Minimum Qualifications Minimum & Preferred Qualifications and Experience

• 5+ years of professional clinical research experience in medical devices;

• Demonstrated scientific writing ability;

• Extensive experience in clinical, medical or biological research, with strong emphasis on experimental design and analytical and statistical techniques;

• Experience with international medical device regulations and submissions;

• Excellent understanding of Good Clinical Practice and regulations;

• Ability to be innovative, resourceful, and work with minimal direction;

• Can communicate effectively in both written and spoken form to management and scientific circles;

• Must be able to travel up to 10% of time, both domestically and internationally;

• Must be able to lift and carry up to 20 pounds;

Preferred Qualifications

• Proven track record and experience in clinical research;

• Proven track record of publication in medical, biological, scientific or public health journals;