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Please email resume@usastaffingnetwork.com a copy of your resume or call 1-585-387-0323. Be sure to reference the Job Number "10739" when inquiring about this job.
 
  

Clinical Research Scientist

Date Posted: 7/30/20
Job Number: 10739
City, State: West Chester, Pennsylvania
Country: United States
Pay Rate: $94K-$115K or higher DOE
Category: General
Term: Direct Hire
Description:

Clinical
Research Scientist to be responsible for the development of
post-market clinical research strategies of orthopedic devices to
support global regulatory and post-market requirements.


Responsibilities to include the following

Work
closely with cross-functional teams Clinical, Medical, Regulatory,
R and D, Marketing to develop post market clinical evidence
generation strategies that consider evidence needs for EU Medical
Device Regulations. Facilitate clinical evidence reviews
with cross functional team to align on clinical evidence strategies,
document , track decisions and risks, and write PMCF Plans.

Develop
and write high quality Post-market Clinical Follow up PMCF plans
and reports with minimal supervision. Support development and
drafting of clinical study protocols, registry plans, epidemiology
studies, informed consents, investigator brochures, and other study
materials where needed.

Review
summaries of clinical evidence and PMCF strategies in other areas of
the Technical Documentation for accuracy and completeness. This
includes the Clinical Evaluation Plan, Clinical Evaluation Report  CEP, Post Market Surveillance Plan and Periodic Safety Update
Report PSUR.

Maintain
strong understanding of evolving post-market evidence requirements
under EU Medical Device Regulation.

Where
required, foster relationships with surgeons, hospitals and research
teams to gain input into study design, evaluate study feasibility,
and identify sites for study execution or data collection. Develop
strong collaborative relationships with the study core team and
others to ensure study progress for assigned projects and that
issues are identified and communicated to leaders.

Partner
with the Contracts and Payments team to ensure timely execution of
all study agreements and corresponding payments for achieved
milestones and deliverables.

Support
clinical scientific discussions with internal stakeholders within
Clinical, Medical, Regulatory, R and D and Marketing to drive
support of the clinical and regulatory strategy, communicate
evidence needs.

Contribute
to appropriate interpretation and dissemination of all evidence
generated, including abstracts, manuscripts, and Clinical Study
Reports CSR, epidemiology study results and clinical literature.

Develop
a strong understanding of the orthopedic device product portfolio
and business needs for clinical evidence to meet regulatory
requirements.

 
Requirements:

  • Bachelors degree in Biological Science or related discipline,
    with a minimum of 4 years’ experience in the medical device
    industry or healthcare field is required  
    Advanced
    technical writing skills is required, with demonstrated experience
    in writing PMCF plans,  reports strongly preferred.  
    Strong
    project management skills required, with demonstrable track record
    of success managing multiple projects simultaneously with minimal
    supervision.  
    Ability
    to communicate effectively and work with teams is required.   
    Previous
    experience developing strategies to generate clinical evidence is
    strongly preferred.


This
position comes with enhanced benefits which include

50 50
shared healthcare cost.



To apply for this job please email resume@usastaffingnetwork.com or
call 1-585-387-0323. Please reference the Job Number "10739" when inquiring about this job.

 
 
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