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Clinical Trial Manager

Date: Mar 11, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  22181  

 

Develop plans and protocols for clinical trials to achieve end results that support the business and Therapeutic Systems business strategies and goals. The Clinical Project Lead has responsibility to design, plan, conduct, and manage clinical research studies.

 

ESSENTIAL DUTIES

  • Create and critique Study Protocols and related Case Report Forms, Investigator Brochures, Informed Consents, and Clinical study reports
  • Prepare regulatory documentation
  • Maintain GCP, IND, and IDE related Clinical study reports
  • Develop study site audit forms for pre-study, study start-up, interim visits, and study termination
  • Establish and manage individual study sites and overall clinical budgets
  • Plan for and orchestrate investigator meetings
  • Investigate serious drug or devise related adverse events
  • Manage the services of a supporting CRO
  • Oversee data collection and data management activities in support of clinical trials
  • Participate on product development teams
  • Maintain frequent communication with customers and other medical professionals, representatives of professional organizations with whom the business is affiliated, and professional/management levels within the business

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

  • An advanced degree in medicine is preferred

 

Experience

Minimum 6 years experience in conducting clinical trials in the medical device field.

  • Extensive experience in managing all phases of multi-center clinical trials either in medical devices, diagnostics or pharmaceuticals

 

Skills

  • Knowledge and use of relevant PC software applications and skills to use them effectively
  • Demonstrated ability to communicate effectively both verbally and in writing
  • Understand clinical trial reporting requirements
  • Understand the physiology and clinical practice of the relevant therapies
  • Understand medical statistics and experimental design
  • Broad knowledge of Therapeutic Systems clinical methods, both laboratory and therapy delivery related
  • Effective leadership, management, and cross-functional skills within a team
  • Positive and a proactive approach to identification and definition of problems and the development and implementation of solutions
  • High level of adaptability, initiative, as well as willingness to take ownership and accept responsibility for actions and decisions
  • Strong interpersonal skills and the ability to represent the business with both internal and external colleagues associated with the organization
  • Excellent organizational skills and proven ability to establish working relationships with all levels of clinical/technical/marketing teams, all in a corporate, clinical, and academic setting
  • A constructive and relentless pursuit of solutions and motivates others to do the same
  • Demonstrate diplomacy and tact while maintaining appropriate assertiveness and persistence

 

-Or-

 

An equivalent competency level acquired through a variation of these qualifications may be considered.

 

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

 

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

 

*CB*

 

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

 

Terumo BCT is committed to providing a safe and secure working environment.  We maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification checks.  To this end, all employment offers for positions in the U.S. are conditional upon successful completion of Terumo BCT's pre-employment screening process.  As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.


Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

 

As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.

 

Our company has almost $1B in annual revenues and has been voted and recognized as:

  • Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
  • Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
  • One of Colorado’s Healthiest Employers by Denver Business Journal (2014 & 2015)
  • Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

 

Our award-winning culture embraces:

  • Leading technology through innovation and R&D
  • Wellness programs
  • Commitment to quality
  • An environment that values, respects and rewards your individual contributions
  • A philosophy of intentional growth and responsiveness to world health issues

 

Click Here to see what our associates have to say about our culture.

 

Each associate has a positive impact on our future by:

  • Connecting to the lives of the patients we ultimately serve
  • Growing through professional and leadership development activities
  • Sharing company success through incentive plans

 

If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.


Nearest Major Market: Denver

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