Project and Site Management Clinical Research Manager I Job
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POST DATE 9/17/2016
END DATE 10/9/2016
Boston Scientific Corporation
JOB DESCRIPTIONWHY JOIN BOSTON SCIENTIFIC NEUROMODULATION IN CALIFORNIA*
We integrate all global operations at our worldwide headquarters in Valencia, California, close to Los Angeles, close to the beach, close to the mountains, close to the desert. All the advantages of Southern California and more affordable than many other areas nearby. Looking for onsite amenities* Check out our on-campus Bistro, Credit Union, private gym, and Toastmasters club. Take advantage of the 360 days of sunshine a year on our basketball and volleyball courts. Join our softball and soccer teams. We even have cricket and dragon boat racing teams! We also offer numerous volunteer activities and events in the wonderful communities of Valencia and Santa Clarita. If you like to work hard and play hard, you'll fit right in. And you'll be well rewarded. Our salaries are competitive. Our benefits package is generous. And our 401K program* Forbes ranks it one of the top 10 in the country!
WHAT MAKES BOSTON SCIENTIFIC NEUROMODULATION SO SPECIAL*
We've seen the difference that neuromodulation technologies, such as spinal cord stimulation and deep brain stimulation, can make. These breakthrough platforms have helped more than 400,000 people worldwide over the past four decades. But there is still enormous potential to help even more people. As a worldwide leader in neurological devices, we strive to improve every life we touch through our dedication to innovation, our commitment to people, and our passion for performance.
Boston Scientific Neuromodulation, a leading producer of medical devices for neuromodulation is looking for a Project and Site Management Clinical Research Manager I to Support PDP Core Teams by maintaining responsibility for Clinical deliverables. Collaborates with cross functional core team members to ensure Clinical projects/programs are carried out consistently with Corporate and Divisional strategies. Interfaces with Sr. Clinical Management, Medical Director, Divisional Management as well as with physicians and external contacts.
DUTIES AND RESPONSIBILITIES
- Supports Regulatory/Clinical strategies as the Clinical Functional Representative and provides Clinical guidance on PDP project teams.
- Manages Clinical Functional Budget.
- Directs forecasting of devices for clinical use.
- Develops clinical study protocols and reviews/approves supporting documentation.
- Negotiates contracts and budgets with clinical study sites and manages external vendors.
- Responsible and accountable for several concurrent clinical studies.
- Hires, trains, develops, mentors and supervises clinical staff.
- Develops and maintains strong relationships with clinical study sites and KOLs.
- Support Site Management functional area including, but not limited to, conducting monitor skills assessments and reviewing monitor reports.
QUALITY SYSTEM REQUIREMENTS
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
- May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
- Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
- Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
- Bachelor Degree in science/health related field (e.g., Biology, Nursing, Biomedical, and Engineering).
- 7+ year's minimum experience of Clinical Trial Project Management
- Prior onsite monitoring experience (e.g. source document verification, training, event reporting, regulatory document review)
- Master's degree preferred.
- 9+ years of related work experience.
- Previous experience with complex, medical device trials
Boston Scientific is an equal opportunity employer.
Nearest Major Market: Los Angeles
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