- Clinical Trials
- Clinical Research
Kelly Services is hiring a Principle Clinical Research Scientist for a major Pharma located in Milpitas CA. Open to remote candidates if the qualifications match the need. This opportunity is 1+ year with chance for renewal based on client need. Kelly offers full benefit package options for this opportunity.
Must have experience as a Clinical Research Scientist as well as experience with device EU MDD/MDR requirements, a PhD or higher education and ophthalmology exposure to be considered.
Reports to the Franchise Platform Leader or Sn Clin Res Mgr, MD CR D;
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
Must have 3-5 years minimal of industry specific or industry equivalent experience.
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
POSITION DUTIES RESPONSIBILITIES:
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
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
About Kelly Services®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.