Clinical Research Specialist
Proclinical is currently recruiting for a Clinical Research Specialist with a pharmaceutical company located in Milpitas, CA.
- 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.
- Responsible for product Global Clinical Plans (GCPs), including PMCF plans for products intended for EU under EU MDR and leading such PMCF planning activities.
Skills and Requirements:
- 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)
If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.