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8 days old

Senior Clinical Scientist

Kelly Services
Irvine, CA 92604
**Clinical Research Scientist (Remote)**


Kelly Services is currently seeking a Senior Clinical Scientist (Project Manager) for a long-term engagement with one of our Global Pharmaceutical clients to work remotely from home.


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**Overview:**


Operating on behalf of the Company, this individual will have strong scientific expertise to provide insights and strategic direction to develop innovative evidence generation and dissemination strategies (EGS / EDS) for New Product Development and Life-Cycle Management (NPD and LCM) projects;


**Responsible for Clinical R&D activities for assigned projects, including** :


+ Develop and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc), ensuring cross- functional alignment;

+ Responsible for delivery of assigned clinical projects, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP);

+ Ensure input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS;

+ Lead in study design to develop appropriate clinical trials to meet the NPD / LCM needs;

+ Lead in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, CERs etc

+ Contribute in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;

+ Responsible for teams interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory Agencies, societies, associations, etc;

+ Foster strong relationships with external stakeholders to shape and influence relevant policies, etc

+ Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement


**Functional and Technical Competencies:**


+ A broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;

+ Ability to provide strategic and scientific clinical research input across NPD and LCM projects, including complex and / or transformational projects;

+ Proven track record in clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations;

+ Comprehensive understanding of clinical trial regulations across multiple regions;

+ Ability to lead teams to deliver critical milestones, including complex projects;

+ Ability to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives;

+ Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders;

+ Ability to influence, shape and lead without direct reporting authority;

+ Change agent in team development and progression;


**Leadership Competencies:**


+ Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

+ Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.

+ Performs other related duties as required.

+ Strong leadership required in alignment with Leadership Imperatives: Connect, Shape, Lead, Deliver as noted below.

1. Connect - foster strategic partnerships with key internal & external stakeholders to ensure development and timely delivery of innovative EGS / EDS

2. Shape build strong relationships with external stakeholders to shape and influence relevant policies

3. Lead continually develop expertise to provide strategic and scientific clinical research capability

4. Deliver ensure clinical programs are delivered on time, within budget and in compliance to regulations and SOPs


**Qualifications:**


+ A Bachelors degree in Biological Science or related discipline.

+ A minimum of 8 years related scientific / technical experience, including influential role within Clinical Research.

+ Focus in medical device / surgical products and Ophthalmology required


\#ACRP


**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: 2022-05-13 Expires: 2022-06-13

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Senior Clinical Scientist

Kelly Services
Irvine, CA 92604

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