Senior Clinical Research Associate

PURPOSE
To support Philips Research Shanghai by running quality clinical research projects. Clinical research projects are aimed to test “new to the world” technologies that have the potential to transform healthcare as we know it and will assist in defining the strategic direction taken by the company. Additionaly, candidate is expected to support Engineering, Regulatory or Marketing needs within required regulatory and scientific framework
PRINCIPAL ACCOUNTABILITIES
- Develop clinical trial protocols to include sound scientific procedures, accurate timelines, and complete scientific references.
- Assures research site qualification and compliance to investigational plans.
- Ensure the timely and accurate compilation of all study data, and compile reports to support regulatory submissions, product documentation and in support of publications.
- Utilizes available tools such as Electronic Data Collection (EDC) to assure timely and accurate study data collection. Manages study and site information in Clinical Trial Management Software (CTMS)
- Assumes the role of subject matter expert for all patient populations involved in assigned research activities. Maintaining and monitoring the ethical conduct of research with human participants. Monitor and report adverse events appropriately. Manage participant concerns when necessary.
- Ensures research processes and procedures are state of the art and meet all regulatory requirements.
- Maintains high throughput and work quality at research sites.
- Assists in training people for all clinical research activities

MAJOR CHALLENGES
The task of the Philips Research organization in Shanghai is to research and develop medical technologies and applications tailored for the China market.
To reach this purpose, we employ people with clinical trial competence and technical competence, who work together in teams. The people with clinical trial competence should contribute to clinical research, through which the technical people will verify and improve the technical solutions.
The major challenges for the candidate is to
1) Ensure quality data through sound scientific protocols, study execution, study monitoring, site / investigator selection and adherence to all regulatory requirements
2) Manage multiple parallel tasks while maintain ethic guidelines.
3) Manage multiple relationships – internal and external to complete tasks successfully
4) Assists in training of new or junior clinical associates
5) Attention to detail

JOB REQUIREMENTS
a) Education:
Bachelor of Science degree in a scientific or health care field required or Masters of Science degree or higher (preferred)

b) Experience:
- Minimum of 2-5 years of clinical research experience preferably in the medical device industry or field of sleep or respiratory medicine
- Demonstrated scientific writing experience
- Knowledge of Good Clinical Practices (GCP’s); and US / international regulations
- Demonstrated efficiency with computer software for document preparation, reports, presentations, communication, e-mail, and data management.
- General understanding of statistics
- Excellent experience in collaborating in teams.

c) Travel Frequency:
< 25%

d) Competency and Skills:
Social skills:
Drive, entrepreneurial behaviour, result and quality driven. People focus.
Excellent communication skills. English language skills to at least CET level 6.
Positive mindset.
“Learn more about Philips Research Asia – Shanghai, please click http://www.research.philips.com/locations/shanghai.html