Job ID 80420
Location: US-PA-Pittsburgh Area
Experience Level: Not Indicated
Education Level: Other
Type of Function: Full-Time Regular
Travel Percentage: 0
Organization Description:
We simplify healthcare by focusing on the people in the care cycle – patients and care providers. Through combining human insights and clinical expertise, we aim to improve patient outcomes while lowering the burden on the healthcare system. Philips delivers advanced solutions for both health professionals, to meet the needs of patients, and empowered consumers for affordable healthcare whether in hospital or at home.
Some product highlights: 256-slice Brilliance iCT scanner, Integrated cath lab, Avalon FM 20 & FM 30 fetal monitors, Ambient Experience MR and CT systems, Philips Lifeline's personal emergency alert service.
To support Philips Home Health Solutions (HHS) / Sleep and Respiratory Care (SRC) Business Units (BU’s) and external customers by managing the successful design, planning, and implementation of quality scientific clinical research that results in data which are timely, and of high quality and integrity, to support Engineering, Regulatory or Marketing needs.
Your Responsibilities:
- Accountable to ensure the timely and accurate completion of all clinical studies (US and international), the compilation of all study data and reports to support regulatory submissions, product documentation and publications
- Attend FDA or other regulatory meetings in support of submissions with clinical data or needs
- Demonstrated proficiency in scientific writing in relevant content areas. Write and edit scientific clinical trial protocols
- Develop and effectively manage relationships (liaison) with key opinion leaders (KOLs), BU leads and executive team members
- Manage financial budgets associated with execution of clinical activities and departmental operations
- Ensure adherence to Quality System Procedures (QSPs) and that all research processes and procedures are state of the art and meet all regulatory requirements. Review and revised as indicated
- Oversee or coordinate departmental or site quality audits
- Manage and mentor clinical associates, ensure professional development and succession planning, conduct performance reviews for direct reports
- Routinely assess performance of the clinical team through a customer satisfaction survey and act on findings
Key Challenges:
- Managing associates who are responsible for multiple projects and tasks
- Establishing and updating priorities
- Achieving goals within annual operating plan
- Adapting in a dynamic business environment
- Developing and maintaining KOL network
- Effective and timely communication
Your Profile:
- Bachelor of Science degree in a scientific or health care field required. Masters of Science degree or higher (preferred)
- Demonstrated scientific writing abilities
- Strong understanding of biostatistics
- Experience:
- Minimum of 5 years of clinical research experience preferably in the medical device industry or field of sleep medicine
- Minimum of 5 years of supervisory/ leadership experience preferred
- Working knowledge of Good Clinical Practices (GCP’s); and US / international clinical research regulations
- Effective oral and written communication skills at multiple levels (e.g. associates, executives, physicians)
- Effective interpersonal skills
- Demonstrated efficiency with common office computer software, e-mail, and data management programs.
* Contacts: Philips
Notes
Philips is an Equal Opportunity Employer
1 comments:
Impressive web site, Distinguished feedback that I can tackle. Im moving forward and may apply to my current job as a pet sitter, which is very enjoyable, but I need to additional expand. Regards. Dr Kodali
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