Clinical Research Operations Specialist

Job Title

Clinical Research Operations Specialist

Job Description

In this role, you have the opportunity to
Strategically partner to manage clinical projects globally for both internal and external stakeholders to optimize product life-cycle, with flawless execution. As part of the Hospital Respiratory Care (HRC) solutions are helping caregivers and lay responders both inside and outside the hospital. We are the number one provider of therapeutic care solutions, saving and improving more and more lives every year.

You are a part of
The Clinical and Scientific affairs team supports clinical studies across Philips. This exciting opportunity is supporting Philips' transition into the EU MDR regulated environment. The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. It is to better identify medical device products and improve transparency through standard data, technological advances and the establishment of an EU database (Eudamed). Similar to the FDA's UDI, MDR will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation. You will have exposure to a multitude of indications, medical devices, and workflow solutions. This position works in partnership with R&D, marketing, regulatory, quality, and legal among other functional areas. This matrix organization approach will improve collaboration and your learning and development across a multitude of disciplines.

Your responsibilities

  • Interface with Philips SVAL (Single Value Added Layer - the enabling functions for Philips) Clinical team in relation to clinical evaluation, clinical investigation, and or studies.
  • Create templates to draft & write clinical evaluation reports
  • Draft and write clinical evaluation reports
  • Opportunity to project manage Class III medical device studies
  • Draft/manage components of clinical investigations/studies as required in coordination with Philips SVAL Clinical team.
  • Help build a system from the ground up to manage clinical studies and evaluation reports
  • Provide support, as required, with CAPA, complaints, or other areas of clinical affairs as it pertains to EU MDR clinical evaluations, investigations, and or studies.
  • Develops and maintains a comprehensive knowledge of EU MDR to ensure adherence to intercompany requirements on the part of Philips HRC.
  • Participates in planning and development activities which support the growth of EU MDR within the company.
  • Responds to and resolves both simple and complex issues under the direction of the Head Regulatory & Clinical Affairs in a timely manner.
  • Support EU MDR activities as required.

To succeed in this role, you should have the following skills and experience
  • Bachelor or Masters in Science or Healthcare discipline
  • Approximately 3+ years related experience in clinical studies (CRO, medical device, IVD and/or site environment)
  • Experience creating clinical evaluation reports and templates
  • Strong experience in using and developing EDC and CTMS systems
  • Needs experience developing and managing EDC, CTMS or QMS systems
  • Good command of written and spoken English language
  • Excellent verbal and written communications skills
  • A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations
  • Excellent record-keeping skills; good documentation practice
  • Manages action items resulting from meetings through resolution, including developing action plans.
  • Analyzes operational data for anomalies, trends, opportunities for improvement.
  • Prepares content for power point presentations which report and make recommendations on the key business drivers for submission to appropriate governing boards and key stakeholders.
  • Develops strategies, recommendations and action plans with the purpose of improving identified inefficiencies and meeting the needs of provider partners based on the critical evaluation of information from multiple sources.
  • Minimal travel, 5-10%

In return, we offer you
We believe that every growth period creates an exceptional career runway. In fact, the Clinical and Scientific Affairs leadership team gets out of bed every morning with the sole focus of growing the business and growing the people who contribute to it. Luckily, you are the benefactor of this unique opportunity and leadership commitment- likely to experience an exciting high stakes, mobility-focused environment from which to create your own future - personally, professionally & financially.

Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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

Contact

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