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18 days old

Global Clinical Strategy Specialist

Kelly Services
Portland, OR 97240
Kelly is hiring a **Global Clinical Strategy Specialist** for one of our medical device clients


+ Remote

+ 3 month contract

+ Hourly rate: Negotiable (Max $71/hr)


**Job Role:**

The Global Clinical Strategy Specialist will be responsible for the development and execution of clinical and economic evidence generation plans for new product introduction globally, expanded adoption of products and securing continued access of approved products. This role will support the Sports Medicine business franchise.

Global Clinical Strategy Specialist will work closely with internal partners including Global Clinical Operations (GCO), Data Analytics, Evidence Evaluation (EE) and Medical Affairs and partners in R&D, Regulatory Affairs, Health Economics /Outcomes Research (HEOR), Marketing and Sales. The Senior Specialist, Global Clinical Strategy will also work closely with external customers, health care practitioners (HCPs) and key opinion leaders (KOLs)/early adopters to generate evidence on the impact of S&N products, and will work with external consultants and vendors to drive evidence generation activities.


**Responsibilities:**

Identify clinical evidence gaps and develop Global Clinical Evidence Plans including short- and long-term strategy, development of methodologically sound clinical study synopses and clinical study plans, claims and publication strategy

Serve on new product development teams for the Sports Medicine Franchise to ensure timely evidence strategy development and execution, as well as clinical support for regulatory submissions to support regulatory approvals for products in key markets where applicable

Develop clinical strategies to ensure MDR readiness and compliance, working closely with Global Clinical and Medical Affairs functions to align on evidence sufficiency. Drive and manage execution of PMCF activities and timely reporting in order to remain on schedule for MDR technical file submissions, Notified Body commitments, and audit readiness

Assist Clinical Study Managers as needed in training investigators, research coordinators, Contract Research Organizations (CROs), central laboratories, and other study vendors on methodological study procedures. Work closely with Global Clinical Operations and Data Analytics from study design through to reporting of results to ensure achievement of business objectives and timely execution.

Work directly with HCPs, KOLs and research centers in clinical evidence generation activities for both Smith+Nephew sponsored research and Investigator Initiated studies


**Experience and Requirements:**

BA or equivalent in Life Sciences required

7 years of relevant experience ideally in the med-tech industry. Experience in sports medicine or orthopedics would be advantageous.

Candidates with medical experience and no med-tech experience will be considered where they can display a clear understanding of business needs and relevant experience in evaluating evidence needs and in designing clinical evidence generation strategies.

Detailed anatomy, physiology and procedural knowledge, and an ability to understand nuance with different pathologies and their associated standards of care and associated outcomes.

A track record of evidence generation and value communication, including clinical trial design, implementation of observational studies, in market clinical evaluations, and real-world data collection activities is preferred.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-06 Expires: 2022-06-06

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Global Clinical Strategy Specialist

Kelly Services
Portland, OR 97240

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