Clinical Operations Manager – Clinical Data Intelligence

You will be responsible for Clinical Operations Management for research partnerships related to the Philips BR eakthrough I nnovation TE ams (BRITE) Clinical Data Intelligence Team, working closely with stakeholders within Philips and at partner sites.

BRITE is the embodiment of Philips' new approach to driving breakthrough innovation. The BRITE approach accelerates innovation by being the organizational sandbox to nurture nascent projects from the early innovation stage to the full ability to scale.

Your role:

• Provide leadership in execution of clinical studies to deliver high quality data to support Philips on time, within budget and in compliance with all applicable regulations and Philips procedures.

• Drive adoption of compliant clinical study execution practices throughout Philips clinical studies including research and testing of products involving human beings.

• Develop and maintain the policies and procedures for the Clinical Operations function.

• Support, update, and maintain the Clinical Trial Management System application for clinical study execution and reporting.

• Drive target versus actual duration for the key metrics (e.g., Protocol Development, Data Capture Development Tool, Site Activation, Study Duration, Database Lock, Clinical Study Report, Studies monitored according to monitoring plan, Studies completed on time, on budget, and without CAPA or major protocol deviations)

• Work closely with CRA’s and research scientists. Interface with Program Management, Clinical Affairs, Regulatory, Legal, and Finance teams and with key roles at clinical study sites.

You're the right fit if:

• You’ve acquired 5+ years of experience in clinical operations management. Experience with research studies of the following types are preferred: observational retrospective data studies, device registry studies, or clinical investigations for prospectively evaluating the clinical performance, effectiveness, or safety of Software as a Medical Device (SaMD).

• You have a Bachelor’s or advanced degree in life sciences, nursing, public health, healthcare administration or a related field.

• Your skills include a strong understanding of Good Clinical Practice (GCP) regulations and regulatory requirements governing clinical trials.

• You have excellent planning, organizational, leadership, communication, and interpersonal skills with the ability to effectively collaborate across multidisciplinary teams. Demonstrated strategic thinking and problem-solving abilities.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Additional Information

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance of Cambridge, MA .

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.

• Discover our rich and exciting history.

• Learn more about our purpose.

• Read more about our employee benefits.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

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It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

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