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Clinical Research Manager

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Date: Sep 14, 2021

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  28053  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. 

JOB TITLE:  Senior Clinical Scientist, Clinical Research and Development

 

 

JOB SUMMARY

This position is an innovative clinical/scientific expert who oversees the development of clinical study plans while providing oversight with minimum direction on clinical strategy, clinical investigation planning, conducting clinical studies, and data analysis. This position may serve as scientific consultant to marketing or research project teams and government agencies. The Senior Clinical Scientist will develop, monitor and interpret results of clinical investigations in preparation for new therapies or device application and will establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of medical device product(s). The Senior Clinical Scientist is expected to perform responsibilities with independence.  Reports directly to the Director of Clinical Research and Development.

  

ESSENTIAL DUTIES

 

  • Design clinical studies in collaboration with cross-functional study teams, defining appropriate hypotheses, study rationale, measurable end points, and methods to ensure scientific integrity of the study in accordance with current regulations and guidelines
  • Manage personnel which may include Medical Writers, Clinical Scientists, and/or Statisticians, leading the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives
  • Work with cross-functional team members to ensure scientific integrity of clinical study data by assisting in the development of study plans, data collection, review, and analysis materials (e.g., CRFs, statistical analysis plans, TLFs)
  • Support in the development of program documents, author and/or critically review regulatory and clinical documents, including clinical plans, pre-submission documents, clinical study protocols and reports, integrated summaries, and responses to US Food and Drug Administration/other regulatory agencies or institutional review boards/ethics committees
  • Support the planning and dissemination of scientific/clinical data through strategically aligned scientific communications (e.g., manuscripts, abstracts, conference presentations, etc.) by providing scientific expertise and authoring support as required. Participates as a key subject matter expert in a highly collaborative cross-functional publication planning team.
  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and KOLs, as well as multidisciplinary internal groups, including other groups in research, business development, commercial operations, legal, etc.
  • Assist in preparation of Clinical and/or Regulatory submissions (e.g., IDE, PMA, CTD, annual reports)
  • Provide scientific guidance to team members while study is active and collaboratively review data to identify and investigate discrepant results or issues as part of multidisciplinary team
  • Review and interpret study data in collaboration with the Medical Monitor and Clinical Affairs staff; prepare and present data summaries, interpretation, and documentation of these reviews
  • Identify clinical study‑related safety trends, and as needed, generate reports to interpret, analyze, and summarize the data and trends.  Assist with identification of data-related or safety‑related queries
     

ADDITIONAL DUTIES

 

  • Assist in training project staff and producing educational/informational documents (e.g., white papers, site initiation slide decks)
  • May participate in meetings with regulatory agencies

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Doctoral degree in biomedical sciences preferred (e.g., MD, DO, PhD, PharmD, DNP); MS in Sciences/Nursing with equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

 

Experience

  • Minimum of 5 years related industry experience in Medical Device or Pharmaceuticals including analyzing, interpreting, and summarizing clinical trial data for internal and external audiences. 
  • Experience with feasibility and pivotal clinical studies
     
    Skills
  • Ability to interpret study results and data analyses
  • Proficient knowledge of medical terminology
  • Expertise with GCP and regulatory compliance guidelines for clinical trials
  • Strong problem-solving skills
  • High attention to detail
  • Able to manage multiple tasks and ensure adherence to timelines
  • Working knowledge of statistics to apply and understand appropriate study design and data analysis of clinical trials
  • Knowledgeable regarding various clinical trial designs and regulatory guidance documents pertaining to trial design and reporting
  • Ability to work effectively independently and with cross-functional teams
  • Must be computer literate with knowledge of Word, Excel, PowerPoint, reference management systems
  • Advanced communication and writing skills and the ability to represent the department to both internal and external constituencies as required
     

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.

 

Additional Physical Requirements

Up to approximately 20% travel may be required including internationally.

 

 

Target Pay Range:  $119,000.00 to $149,000.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  10.0%

 

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

 

  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
  • We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
  • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect – Appreciative of others
    • Integrity – Guided by our mission
    • Care – Empathetic to patients
    • Quality – Committed to excellence
    • Creativity – Striving for innovation
  • We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

 

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 Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification. 


Nearest Major Market: Denver

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