Share this Job

Clinical Research Lead - Post Market Clinical Follow-up

Apply now »

Date: Nov 10, 2020

Location: San Francisco, CA, US

Company: Terumo BCT, Inc.

Requisition ID:  26916  

 

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:  Clinical Research Lead, Post Market Clinical Follow-up (REMOTE POSITION)

 

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 studyrelated safety trends, and as needed, generate reports to interpret, analyze, and summarize the data and trends.  Assist with identification of data-related or safetyrelated 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
  • 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.

 

  • 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: San Francisco
Nearest Secondary Market: Oakland

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