In this role, you have the opportunity to
The Senior Clinical Project Manager is responsible for managing and meeting the objectives of clinical studies, satisfying all applicable regulatory standards and company requirements. This position is able to handle the most complex clinical studies and is also able to provide mentoring to other members of the department. Position will be responsible for all project management activities including the successful execution of clinical milestones in compliance with applicable clinical/regulatory standards, facilitation of effective inter-and intra- departmental relationships, evaluation of new processes and methods, and achievement of Clinical Affairs departmental corporate goals and objectives on time and on budget.
You are responsible for
Provide study management as Project Leader of key clinical trial(s) and assure successful conduct of assigned clinical programs consistent with R&D and Marketing plans and applicable regulations/policies. This includes interfacing with representatives from key functional groups including: Clinical Operations, Quality Monitoring Manufacturing, Sales, Marketing, Customer Service, Finance, Regulatory Affairs, R&D, Advanced Development and Global Clinical Groups.
Works with Sr. Operations and Clinical Research Associate Managers to develop department plan, objectives and trial needs assessment.
Works with Sr. Operations and Clinical Research Associate Managers to determine study objectives, strategy, scope and schedule in order to meet business needs.
Develops and maintains strong working relationships with key physicians and Clinical Development to provide input into clinical trial design and execution.
Develops and maintains strong working relationships with the Clinical Study team ensuring that the progress and status of the clinical trials is effectively discussed and communicated, and also providing leadership and serving as a role model.
Reviews and provides input on the Investigational Plan/protocol in consultation with the clinical development team, cross-functional project team, investigators and the clinical team.
Assists in the selection of Principal Investigator’s and clinical sites.
Interfaces with, and assures training of investigators, site staff and Philips staff.
Ensures the development, review and approval of case report forms (CRFs) for the clinical study.
Provides guidance to the Clinical Study Team in development of study materials such as patient brochures, patient recruitment materials, Manual of Operations, newsletters, etc.
Interfaces with Philips regulatory and with regulatory agencies as required.
Assists in the selection and management of CRO(s) and core laboratories.
Provides direction and oversees all outside CRO(s) associated with a trial to ensure adherence to contract, deliverables, data collection and other trial associated activities.
Mentors less senior level project managers.
Enlists support and specifies tasks for various clinical team members to assure meeting study objectives on schedule.
Works with Clinical Study Team to ensure that all necessary information for post study reports and publications are provided.
Develops, manages and is responsible for budgets for assigned study(s).
Complies with applicable FDA and international regulatory laws/standards, the Philips Code of Conduct, including company-wide and departmental Standard Operating Procedures (SOPs).
Performs other clinical duties when requested
To succeed in this role, you should have the following skills and experience
Bachelor’s degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field.
Minimum of 10 years’ experience directly supporting clinical research or similar experience in a medical/scientific area. (Master’s degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience.)
Clinical research experience in the field of medical devices is desired.
Experience working with a global team is preferred.
Experience managing CROs, central laboratories, and other clinical study vendors
Demonstrated knowledge of FDA regulations concerning the conduct of pre-clinical and clinical studies. Knowledge of international regulations for clinical studies desired
Strong command of GCP/ ICH guidelines
Effective analytical and problem solving skills
Excellent interpersonal and effective verbal and written communication skills and be able to effectively work across departments with diverse needs
Excellent organizational and time management skills
Ability to work in a highly matrixed team environment
Ability to adapt to changing priorities
Experience with or desire to use experience to create innovative infrastructure and "best practices" in concordance with core purpose is highly desirable
Knowledge of and skill in using Microsoft Office suite, specifically, Word, Excel, PowerPoint, and Outlook
Position may require up to 30% travel
Why should you join Philips?
Working at Philips is more than a job. It’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 continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In 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.