• Participate in the design and execution of global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management. • Manage study preparation, activation, enrollment, submission, maintenance and closure activities. • Participate in administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets. • Interface with representatives from key functional groups to drive product development within core teams, and clinical wide or cross-departmental initiatives. • Ensures appropriate oversight of clinical study by internal and external resources including, but not limited to monitoring staff, CROs and core laboratories. • Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders. • Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers. • Supervise training of investigators, site staff and field clinical staff. • Evaluates clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents. • Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions. • Regularly communicates study status to senior management and represents organization to key customers. • Other duties as assigned.