Your role:

• Owning the overall study process and adherence to clinical trial procedures by keeping oversight, identifying possible problems/risks, creating mitigation plans, and taking actions or corrective actions using timely communication for daily monitoring and site mgmt.

• Supporting site identification, selection, i.e. recruitment and qualification, and initiation. As well, developing the monitoring plan for clinical studies.

• Acting as Clinical Study Manager for designated clinical studies under the guidance of your manager and supporting other studies in this role as applicable. Contributing to protocol development and study related documents, such as informed consent related to monitoring activities.

• Supporting electronic data capture (EDC) user acceptance testing and training as applicable, while liaising with project team members regarding study site issues. As well as assisting with resolution of investigational site/data queries.

• Initiating study status reports, essential documents, and accurate study files, while supporting the development of regulatory binders and investigational product shipments as needed.

• Traveling to study sites for meetings and monitoring visits upon request (i.e. 60% travel of which 10% international).

You're the right fit if:

• You’ve acquired 5+ years of experience in conducting/executing clinical trials (healthcare setting, CRO, medical device and/or in medical technology and/or industry) as a Senior Clinical Research Associate.

• Your skills include a demonstrated working knowledge of GCP, ICH guidelines, FDA/EU regulations.

• You have a bachelor’s degree in biological sciences or healthcare.

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

• You’re autonomous, fluid and have the ability to follow through on timelines, projects and related tasks with limited direction. You have a proven track record for collaborating across multiple cross functional teams and are a strong and efficient communicator, both written and verbal.

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.

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 to Cambridge, MA .

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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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