Clinical Research Manager
Working on behalf of the Medical Device Group, this clinical research Manager will lead in the development of clinical evidence generation and dissemination strategies (EGS/EDS) across assigned New Product Development and Life-Cycle Management (NPD / LCM) projects.
Role Responsibilities:
• Responsible for Clinical R&D activities for assigned projects, including:
• Developing and delivering appropriate Global EGS / EDSto support NPD /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 programs, 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);
• Ensuring input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS;
• Leading a team of clinical research scientists to design appropriate clinical trials to meet the NPD / LCM needs;
• Leading teams to ensure appropriate interpretation and dissemination of all evidence generated, based on EDS, including CSRs, CERs, abstracts, manuscripts, etc
• Contributing 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;
• Fostering strong relationships with external stakeholders to shape and influence relevant policies, etc
• Partnering with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement
Reports to: Franchise Platform Leader or Sn Clin Res Mgr
Location: West Lothian