In this role, you have the opportunity to
Strategically partner to monitor and manage clinical projects and clinical staff globally for both internal and external stakeholders to optimize product life-cycle, with flawless execution.
You are responsible for
Ensure the clinical studies are monitored and conducted according to procedures including up to date and complete trial master files, regular review of data, and assurance that monitoring reports are completed within two weeks of visit date.
Ensure that monitoring plans are created and followed with monitoring documentation to support this included in the applicable Trial Master Files.
Act as Clinical Study Manager for designated clinical studies under the guidance of your Manager and may support other studies in this role as applicable.
Attend all required meetings and provide updates to team.
Support EDC user acceptance testing and training as applicable
Oversee and support the creation of the trial master file, regulatory binder, source documents, and investigational product ordering, shipping, and associated documentation
You are a part of
The Clinical and Scientific affairs team supporting clinical studies across Philips. This exciting opportunity ensures 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. This position will be responsible for ensuring all clinical studies for multiple projects are assigned to appropriate clinical staff, timelines and budget are met, and all deliverables completed per aligned project plans.
To succeed in this role, you should have the following skills and experience
Bachelor or Masters in Science or Healthcare discipline
5+ years related experience in clinical studies (healthcare setting , CRO, medical device and/or pharmaceutical company and/or industry)
At least 3 years of experience as a Clinical Research Associate monitoring clinical studies.
Experience in using EDC and CTMS systems is desirable
Knowledge of Sharepoint and Excel is helpful in this role
Good command of written and spoken English language
Excellent verbal and written communications skills
Excellent interpersonal and organizational skills
A pro-active, committed and motivated attitude
A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations
Excellent record-keeping skills; good documentation practice
Ability to maintain excellent working relationships with a broad range of clinical study staff.
Ability to work well in a team environment but also independently without significant oversight
Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
Flexibility in work hours and readiness to travel. Travel typically no more than 25% per month but could vary from project to project.
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.