Specialist Sr, Clinical Trials Job
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PRIMARY LOCATION: US-MN-Arden Hills
ADDITIONAL LOCATIONS: (n/a)
REQUISITION ID: 278755
At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In Cardiac Rhythm Management (CRM) we offer solutions for treating irregular heart rhythms and heart failure, and protecting against sudden cardiac arrest. Boston Scientific develops, manufactures, and markets a broad array of products and services that enable less-invasive care for some of the most threatening cardiac conditions. We've been expanding indications and conducting pivotal research for nearly 20 years, resulting in increased access to the lifesaving and life-enhancing benefits of ICD and CRT therapies.
Responsible for the 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 a given therapeutic area.
- 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. May lead studies executed by a CRO.
- 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.
- Bachelor's degree and 5+ years of related work experience or an equivalent combination of education and work experience.
- 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.
- Ability to use in-depth knowledge of business unit functions and cross group dependencies/relationships.
- Clinical trial experience required.
- CRM, EP or Left Atrial Appendage Clinical trial or technical experience desired.
*level of position will be determined by candidate's experience
QUALITY SYSTEM REQUIREMENTS:
- 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.
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
BOSTON SCIENTIFIC (NYSE: BSX) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit us at www.bostonscientific.com.
Boston Scientific (NYSE: BSX) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.
Boston Scientific is an Equal Opportunity Employer.
Posting Notes: US-MN-Arden Hills||(n/a)||Clinical||(n/a)
Nearest Major Market: Minneapolis
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