- 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 of Clinical and Medical Affairs.
- 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'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.
- 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.
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Clinical Operations Manager – Clinical Data Intelligence - Cambridge, United States - Philips
Description
Job Title
Clinical Operations Manager – Clinical Data Intelligence (Cambridge, MA)Job Description
Clinical Operations Manager – Clinical Data Intelligence
You will be responsible for Clinical Operations Management for research partnerships related to the Philips BReakthrough Innovation TEams (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:
You're the right fit if:
Additional Information
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.
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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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
Clinical Operations Manager – Clinical Data Intelligence professionals in Cambridge
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Rick Zhou
Private Equity Analyst