Share this Job

Clinical Affairs Manager - PMCF

Apply now »

Date: Nov 10, 2020

Location: San Francisco, CA, US

Company: Terumo BCT, Inc.

Requisition ID:  26917  

 

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 Affairs Manager – PMCF (REMOTE POSITION)

 

 JOB SUMMARY

Working under minimum direction, develops objectives, plans, and processes for post-market clinical follow-up (PMCF) requirements achieving results that support business strategies and goals.  Responsible for developing the PMCF plan for Terumo BCT products, overseeing registries, clinical trials, clinical studies, national validation studies, post-market surveillance, and hemovigilance studies to support the content of PMCF reports and other regulatory documents. Reports directly to the Senior Manager, Global Clinical Affairs.

 

ESSENTIAL DUTIES

  • Establishes processes and oversees PMCF requirements for Terumo BCT products.
  • Manages clinical trial reporting requirements, the physiology and clinical practice of the relevant therapies, and medical statistics, including experimental design.
  • Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
  • Develops clinical planning documents and regulatory documents that support the clinical program strategies and best practices and must revise as appropriate to meet challenging needs and requirements for the business area and company.
  • Determines resource requirements and qualifications to support effective implementations and outcomes of studies and provides feedback and observations that may be of clinical or product importance.
  • Participates in clinical trial-related meetings with domestic and foreign regulatory agencies.
  • Works closely with KOL’s to plan clinical programs and resolve clinical related issues.
  • Understands customer issues and works to resolve problems with product, procedures, and policies that drive change where necessary to resolve these issues.
  • Qualifies and manages the services of a supporting Contract Research Organization (CRO).
  • Ensures maintenance of study files.
  • Maintains a working knowledge of International Organization for Standardization (ISO), Good Clinical Practice (GCP) requirements, medical device industry practices, European Medical Device Regulations (EU MDR), and International Conference on Harmonization (ICH) Guidelines. Works closely with senior management and cross-functional teams to define PMCF program strategies that support business areas objectives and regulatory requirements.
  • Maintains contacts involving significant responsibility with customers and other medical professionals, representatives of professional organizations with whom the business is affiliated, and professional/management levels within the business.
  • Develops and manages budgets for clinical programs.
  • Participates in internal and external audits to monitor and identify improvement opportunities across the organization.
  • Provides knowledge and subject matter expertise for internal and external clinical training.
  • Hires, trains, coaches, counsels, and evaluates the performance of direct reports

 

OTHER DUTIES AND RESPONSIBILITIES

  • Understands short-term and long-term business goals.
     

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.

  • Advanced degree in medical-related field is preferred. 

 

Experience

Must have at least 8 years experience in conducting ,managing, and/or designing all phases of multi-center clinical trials either in medical devices, diagnostics or pharmaceuticals.

 

Skills

  • Knowledge of relevant PC software applications and skills to use them effectively.
  • Demonstrated ability to communicate effectively both verbally and in writing.
  • Strong interpersonal skills and the ability to represent the business with both internal and external contacts. 
  • Ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence. 
  • Highly adaptive to meet changing business and client needs.
  • Demonstrate effective leadership, management, cross-functional team skills, self-direction, and ability to work independently. 
  • Positive and proactive approach to identification and definition of problems, leading to timely development and implementation of solutions.  It is highly important to be constructive and have a relentless pursuit for solutions while motivating others to do the same. 
  • Requires a high level of initiative as well as willingness to take ownership and accept responsibility for actions and decisions.

-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.

 

Travel up to 30% may be required.

 

  • 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, Physiology, Medical, Manager, Healthcare, Management, Research