Boston Scientific Corporation
Purpose and Passion \u2022 Comprehensive Benefits \u2022 Life-Work Integration \u2022 Community \u2022 Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we\u2019re solving some of the most important healthcare industry challenges. Together, we\u2019re one global team committed to making a difference in people\u2019s lives around the world. This is a place where you can find a career with meaningful purpose\u2014improving lives through your life\u2019s work. About This Role: The Clinical Trial Manager is responsible for\u00a0the design, planning, execution and leadership of clinical studies and clinical programs worldwide. Responsible for leading cross functional clinical teams in support of the organization's business objectives for product development and\/or commercialization. Possesses a technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within Rhythm Management. Your responsibilities will include: Writes study protocols, protocol amendments, informed consents, clinical study project timelines and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice. Efforts and leadership supports product approval, indication expansion and claim support, and mandated post market requirements. Leads the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback\/direction. Provides project leadership and scientific expertise throughout the development and implementation of local or global clinical studies. Provides clinical input for new product development, post market surveillance, recertification and business development. Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables. Interacts with regulatory agencies as needed, and will use their scientific knowledge in order to provide directives to staff as well as study sites. Facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, Key Opinion Leaders\/investigators and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff (BPT\/PIB, etc.). Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines. Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings. Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc. May include clinical risk management activities including input into Hazard Analyses, product FMEA and DFUs and authorship of Clinical Evaluation documents (CES, CRBA, CDSR) for identification of harms and support of safety performance for product approval. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. What we\u2019re looking for in: Basic Qualifications Bachelor\u2019s degree and 6 years of related work experience or an equivalent combination of education and work experience. Ability to use in-depth knowledge of business unit functions and cross group dependencies\/relationships. Clinical trial experience required. Preferred Qualifications CRM Clinical trial, Diagnostics (e.g. Heart Failure sensing) or technical experience desired. Strongly prefer a professional with a wide-range of experience and expertise in a specialized technical field. Ability to apply comprehensive technical knowledge of a particular field to resolve complex issues in creative ways.
Boston Scientific Corporation
Website : http://www.bostonscientific.com
Our products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain conditions. We continue to innovate in these areas and are extending our innovations into new geographies and high-growth adjacency markets.