FierceBiotech and FiercePharma Jobs
Clinical Specialist - Boyle & Associates
Apr 18
Location: Multiple openings, Categories: Pharmaceutical
Position Description
General Description: The Clinical Specialist (CS) supports the project manager through collaboration with clinical investigators and members of the team participating in sponsor driven clinical studies. The role focuses on on-site support as well as other assigned areas within the scope of clinical study management.The CS is responsible for managing and meeting the milestones of the clinical study in compliance with applicable clinical and regulatory standards and in alignment with business needs.
Duties and Responsibilities: Interface with, and assure training of physicians, site staff, and clinical staff on product use and its mechanism of action. Serve as the primary resource for Clinical Support in the areas of surgical treatment, troubleshooting, educating physicians on proper clinical usage of all company products and first line respondent to customer needs and complaints. Collaborate with representatives from key functional groups (Research & Development, Manufacturing, Business Development, and Regulatory Affairs). Facilitate conference calls, meetings and training events. Assist in the following activities: compilation and review of adverse event information; follow-up and resolution of site issues; compilation, review and conclusion of device complaints; control of device allocation, distribution and reconciliation and other clinical activities. May provide work direction to Clinical Research Assistant(s). Provide field-based resource to support clinical trial enrollment, product training/in-service, support clinical trial monitors and the data collection efforts as required, and other activities related to clinical use of products/product candidates. Support design review, customer feedback, and reimbursement initiatives from clinical perspective.Support the overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.
Requirements Position may require greater than 60% travel. Must have the ability to travel within 24 hours notice. Have a desire to teach and drive utilization/adoption of a new technology. Mobility Requirements: Able to stand/sit/walk up to 8 hrs/day; able to bend/stoop/reach on a regular basis during the work day; able to travel independently. Dexterity and Vision Requirements: Able to use computer to develop, review, and communicate job-related documentation. Hearing requirements: Able to participate in meetings and conference calls.Education: RN with at least 1 year of experience in the operating room environment or a Bachelor’s degree or advanced degree (e.g. BA, MS, MA, or MPH) in a scientific field of study (e.g. biological science, social science, engineering, or other related medical/scientific field) with at least 2 years experience supporting medical device use in an operating room environment. Proficient knowledge of medical terminology, anatomy, physiology, pathophysiology, and aseptic technique. Desired/Preferred QualificationsKnowledge of clinical research study design, Good Clinical Practices, and global clinical regulations, including FDA regulations and ICH guidelines, for devices, biologics, and/or pharmaceuticals.Ability to coordinate planning efforts with the clinical department and other business groups, including defining customer requirements and management needs.
Experience:
Skills: Demonstrated ability to successfully accomplish the following: build rapport easily and provide product expertise across multiple education levels; cultivate relationships with customers and stakeholders in cross-functional environment; clearly and effectively communicate verbally and in writing; motivate and hold individuals accountable to deliverables; achieve corporate objectives and milestones with a resolution-focused mentality; identify and adapt to shifting priorities and competing demands; maintain composure in difficult circumstances; recognize issues and implement solutions, including identifying and involving the appropriate decision makers; provide performance feedback; appropriately respond to feedback from customers and key functional groups; accept challenging assignments; engage in relevant developmental activities.
