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Clinical Research Lead - Post Market Clinical Follow-up

Date: Jul 27, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  23422  

 

JOB SUMMARY

This position is a clinical representative who contributes to project plans and provides oversight on clinical strategy, clinical investigation planning, conducting clinical studies, and data analysis.  The position will collaborate with a cross functional project team and will define post market clinical follow up (PMCF) activities, may conduct clinical evaluations, may participate in assessment of clinical benefit-risk profile and will support post market surveillance (PMS) activities. This position will contribute to monitoring and interpreting results of clinical investigations in preparation for new drug, therapy, or device applications and may serve as a scientific consultant to marketing or research project teams and government agencies. 

 

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
  • Provide direction and guidance to the cross-functional project team on PMCF activities
  • Plan, execute, and finalize deliverables for CE marking products under European Medical Device Regulations (MDR) including but not limited to the PMCF plan and PMCF Report within the triple constraints of delivering on time, within budget and scope objectives
  • Author or support development of program documents, including but not limited to educational/informational documents (e.g., white papers, site initiation slide decks), clinical protocols, informed consent forms, clinical study reports, abstracts and manuscripts, presentations, investigator brochures, and various other internal and external documents and communications as needed
  • Assist in preparation of Clinical and/or Regulatory submissions (e.g., IDE, PMA, CTD, annual reports, CER, etc.)
  • Research, develop, and write clinical/scientific materials, including background summaries, conclusions/discussion sections, or data summaries for regulatory documents
  • Author and/or critically review and approve a wide variety of regulatory, technical, scientific, 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, content posted to clinicaltrials.gov, etc.
  • Work with cross-functional team members to ensure scientific integrity of clinical study data by assisting in the development of data collection, review, and analysis materials (e.g., CRFs, statistical analysis plans, TLFs)
  • Provide scientific guidance to team members while study is active and review data to identify and investigate discrepant results or issues
  • Review and interpret study data in collaboration with the Medical Monitor and Clinical Affairs staff; prepare and present data summaries 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
  • Interact with Key Opinion Leaders and Advisors
  • Assist in training project staff and the Clinical Affairs department with developing operational strategies for clinical research studies and development programs (e.g. Investigator selection, CRO selection, timelines)
  • Manage and lead the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives

 

OTHER DUTIES AND RESPONSIBILITIES

  • Work as a cross-functional team member with peers and other levels within entire organization and with external peers

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

PhD Scientist preferred; Advanced Scientific degree or BS/BA 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 2 years related industry experience in Medical Device or Pharmaceuticals including analyzing, interpreting, and summarizing clinical data for internal and external audiences
  • Previous experience as a clinical research associate/field monitor, clinical study project manager, or regulatory medical writer is a plus
  • Understanding of European Medical Device Directive (MDD) and MDR
  • Experience with post-market clinical follow-up planning and/or post-market surveillance planning is a plus
  • Experience with developing registries and utilizing Real World Evidence data to confirm performance and safety of medical devices is a plus
  • Experience with regulatory submissions utilizing Real World Evidence is a plus

 

Skills

  • Ability to interpret study results and data analyses
  • Proficient knowledge of medical terminology
  • Expertise with GCP and regulatory compliance guidelines for clinical trials
  • Possess 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
  • Knowledge and use of relevant PC software applications including Word, Excel, PowerPoint, reference management systems and skills to use them effectively
  • Demonstrated ability to communicate effectively both verbally and in writing 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.

 

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

Job Segment: Clinic, Medical, Medical Research, Clinical Research, Healthcare, Research