Clinical Research Project Manager - Ophthalmology Medical Device
Kelly Science & Clinical
Location: Irvine, California
Internal Number: US33JLKP_BH3675797
Clinical Research Scientist (Remote)
Kelly Services is currently seeking a Clinical Research 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 may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
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 team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, 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:
Thorough understanding of clinical research science and processes along with 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 delivering clinical programs within 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;
Leadership requirement – ability to influence, shape and lead without direct reporting authority;
Change agent in team development and progression;
Experience in effective management of project budget processes
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.
Connect - foster strategic partnerships with key internal & external stakeholders to ensure development and timely delivery of innovative EGS / EDS
Shape – build strong relationships with external stakeholders to shape and influence relevant policies
Lead – continually develop expertise to provide strategic and scientific clinical research capability
Deliver – ensure clinical programs are delivered on time, within budget and in compliance to regulations and SOPs
A Bachelor’s degree in Biological Science or related discipline. Advanced degree in Ophthalmology, Optometry and PhD in related field is preferable.
A minimum of 8 years related scientific / technical experience, including leadership / management role within Clinical Research.
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.
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