Kelly LifeScience & Clinical is currently seeking a Principal Clinical Research Scientist for a long-term engagement at one of our Global clients in Milpitas, CA. This role can be remote but would like someone within close distance for on-site needs when requested.
The opportunity role is a full-time, fully benefited position with no tenure cap / end date. As a Kelly employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You’ll also be eligible for paid time off, including holiday, vacation, and sick/personal time.
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 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 New Product Development and Life-Cycle Management (NPD and 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.
Act as the subject matter expert (SME) for product-specific and state of the art literature reviews, particularly for clinical evaluations. Lead the clinical aspects of labeling review for on-market products undergoing transition to EU MDR with respect to sufficient clinical evidence.
Responsible for product Global Clinical Plans (GCPs), including PMCF plans for products intended for EU under EU MDR and leading such PMCF planning activities.
Medical Device clinical research regulatory experience required
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.
Experience with supporting EU MDR documents (filling & reporting) required (experience with on-market products or EU MDR requirements)
Experience with attend project team meetings to get up to speed on project scopes and relevant deliverables
Experience with Literature reviews as a clinical scientist or within clinical trial reviews (technical writing strongly preferred)
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.
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.
Strong leadership required in alignment with Client Leadership Imperatives: Connect, Shape, Lead, Deliver as noted below.
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.
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Clinical Study Reports
New Product Development