Clinical Research Program Manager

IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME

BASIC QUALIFICATIONS:

EDUCATION REQUIRED:
• Bachelor’s degree
 YEARS OF EXPERIENCE:
• 7+ years of clinical research experience in medical/scientific area (Advanced degree will count as 2 years of experience)
 
 DESIRED/PREFERRED QUALIFICATIONS: 
• Experience with global clinical trials
• Aortic disease or cardiovascular disease knowledge and experience
• MD or Doctorate/Master degree in Life Science/Engineering/Public Health degree preferred
• Demonstrate high-level of strategic thinking
• Navigate complex challenges and is comfortable with ambiguity
• Thinks “outside the box” (Innovative/Visionary)
• Experience managing cardiovascular medical device and/or pharmaceutical trials
• Work effectively on cross-functional teams
• Deliver results and is solution oriented
• Manage projects effectively
• Track record of successful management experience. Experience with management of external consultants and regional teams desirable
• Negotiate with health authorities/regulatory bodies around the world
• Knowledge of cardiovascular disease
• Influence  up, down, and cross functionally
• Ability to work in a highly matrixed team environment
• Customer focused
• Excellent understanding of biostatistics and trial design
• Excellent written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
• Good prioritization and organizational skills
• Strong knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003 and 14155:2011
• Strong knowledge of World Health Organization (WHO) Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
• Proficient in MS Office products, word processing, spreadsheets, etc.

PHYSICAL JOB REQUIREMENTS: Physical capabilities to perform the job
• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to be independently mobile.  The employee is also required to interact with a computer, and communicate with peers and co-workers.
• Ability to travel up to 25%

MEDTRONIC OVERVIEW:
Together, we can change healthcare worldwide.  At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday.  It is what makes this an exciting and rewarding place to be.
We can accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team.  Let’s work together to address universal healthcare needs and improve patients’ lives.  Help us shape the future.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law.  In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:  http://www.uscis.gov/e-verify/employees
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.