Job title
Senior clinical research associate
Job description
If you are a colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon requestYou may contact 888-367-7223, option 5, for assistance.
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
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 philipsThis exciting opportunity ensures exposure to a multitude of indications, medical devices, and workflow solutionsThis position works in partnership with r&d, marketing, regulatory, quality, and legal among other functional areasThis matrix organization approach will improve collaboration and your learning and development across a multitude of disciplinesThis 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
3+ years related experience in clinical studies (healthcare setting , cro, medical device and/or pharmaceutical company and/or industry)
At least 2 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
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.
Flexibility in work hours and readiness to travelTravel may be up to 50% but typically no more than 25% per month.
In return, we offer you
We believe that every growth period creates an exceptional career runwayIn 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 itLuckily, 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 jobIt’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 continuumOur people experience a variety of unexpected moments when their lives and careers come together in meaningful waysLearn 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 blogOnce there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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 workforceIn 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.
Equal employment and opportunity employer/disabled/veteran
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