Job Title – Clinical Affairs Consultant
Duration - 12 months
Location - Bothell WA
In this role, you have the opportunity to
Strategically partner to manage clinical projects and clinical staff globally for both internal and external stakeholders to optimize product life-cycle, with flawless execution.
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 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.
You are responsible for
o Ensure the clinical studies are 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.
o Ensure that monitoring plans are created and followed with monitoring documentation to support this included in the applicable Trial Master Files.
o 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.
o Attend all required meetings and provide updates to team.
o Support EDC user acceptance testing and training as applicable
o Oversee and support the creation of the trial master file, regulatory binder, source documents, and investigational product ordering, shipping, and associated documentation
To succeed in this role, you should have the following skills and experience
o Bachelor or Masters in Science or Healthcare discipline
o Approximately 5 years related experience in clinical studies (healthcare setting , CRO, medical device and/or pharmaceutical company and/or industry)
o At least 2+ years of experience as a Clinical Research Associate monitoring clinical studies.
o Experience in using EDC and CTMS systems is desirable
o Knowledge of Sharepoint and Excel is helpful in this role
o Experience with direct line management of staff including hiring, training, oversight and mentoring
o Good command of written and spoken English language
o Excellent verbal and written communications skills
o A pro-active, committed and motivated attitude
o A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations
o Ability to work very accurately and thorough
o Excellent record-keeping skills; good documentation practice
o Maintain excellent working relationships with a broad range of clinical study staff.
o Work well in a team environment but also independently without significant oversight
o Efficiently organize and prioritize work within a multifaceted framework and set deadlines.
o Flexibility in work hours and readiness to travel.
Best,
Kushal Shah
APN Software Service INC
609-357-9180 (Direct)