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Senior Clinical Trial Manager

Date: Nov 29, 2018

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  22182  

 

Manages operational implementation of both pre- and post-market clinical trial(s) in the US and/or globally.  Assists with development and ensures adherence to study budget and timelines.  Ensures compliance with the Clinical Investigation Plan (CIP), applicable regulations, and established SOPs/processes.  Recommends and implements innovative process ideas to positively impact clinical trial management.  Manages vendors required to efficiently execute and complete clinical studies, effectively drives performance to ensure timelines and goals are met.  Provides leadership, coaching, mentoring and training to study team members as well as liaison with cross-functional department personnel.  Maintains and applies a thorough understanding of GCP/ICH/ISO regulations. 

 

ESSENTIAL DUTIES

  • Manages the operational aspects of clinical trials including but not limited to document development, investigator recruitment, patient enrollment, trip report review, study trackers, and study specific guidelines/processes
  • Assists in the development of study budgets. Manages and ensures adherence to overall study and site budgets and timelines for clinical studies
  • Develops and revises clinical planning documents that support the clinical program strategies
  • Author and/or edit, ensuring completeness and accuracy of content of Clinical Trial documents such as Clinical Investigation Plans, Informed Consent Form templates, Case Report Forms, Statistical Analysis Plans, Clinical Project Plans, Study Management and Monitoring Plans, Clinical Investigation Reports, training materials, contracts, etc. ensuring quality, consistency, management, and adherence to established regulations/processes
  • Develop and initiate feasibility studies and patient recruitment strategies
  • Act as primary contact for study team members and managing external vendors, providing training, guidance, and mentoring to study team members and may provide back-up coverage to other Clinical Trial Managers
  • Conduct or participate in study site visits, as necessary
  • Coordinate investigator meetings; prepares presentation materials and presents project information at internal and external meetings (eg, study site, vendors)
  • Assures quality and integrity of clinical trial data by monitoring patient status during the course of the study. Assures quality of data collection and alert of applicable personnel if safety or study conduct issues are identified.   Assures that monitoring visits are scheduled at appropriate time intervals and adjusted to manage various patient accrual rates.  Assures that CRAs manage sites to ensure timely, accurate collection of data and query resolution.  Tracks data query rates; identifies and provides solutions for data trends
  • Ensures maintenance of the Trial Master File
  • Partner and coordinate efforts of cross-functional project members to ensure efficient communication and implementation of projects
  • Contributes to the preparation of relevant clinical sections for regulatory documentation, such as IDE, IND, or CE-Mark Technical Dossier
  • Coordinates the investigation and verifies reports of serious/unanticipated drug or device related adverse events, device deficiencies, and protocol deviations and ensures follow-through, resolving and/or escalating study-related issues in a timely fashion
  • Participates in internal and external audits to monitor and identify improvement opportunities within Clinical Affairs

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

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

  • Advanced degree preferred

 

Experience

  • Minimum 6 years experience and/or training in managing clinical trials, one of which includes leading global clinical trials or global project management
  • Experience conducting all phases of multi-center clinical trials either in medical device, diagnostic, or pharmaceutical industry
  • Knowledge of clinical study (GCP) and good working knowledge of regulatory requirements (ISO, FDA, ICH), both US and International

 

Skills

  • Demonstrated effective leadership, management, cross-functional team skills, self-direction, and ability to work independently
  • Has a thorough understanding of applicable GCP, CFR, ISO regulations
  • Demonstrates ability to function independently and cooperatively, and exercises judgment in developing methods, techniques and evaluation criteria for obtaining solutions and resolving problems.
  • Must have a positive and proactive approach to identification and definition of problems, leading to proactive development and implementation of solutions 
  • Requires a high level of adaptability, initiative, and willingness to take ownership and accept responsibility for actions and decisions of the team
  • Possess organizational skills
  • Demonstrated ability to communicate effectively both verbally and in writing
  • Posses  interpersonal skills and the ability to represent the business area with both internal and external contacts
  • Demonstrated ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence
  • Knowledge and use of relevant PC software applications, Microsoft Office,  and skills to use them effectively

 

-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.

 

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.

 

We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks.  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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