Senior Clinical Trial Manager

Senior Clinical Trial ManagerDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.About the role: The Senior Clinical Trial Manager will lead the design, planning, execution, and oversight of global clinical studies for the Renal Denervation portfolio. This individual will manage cross-functional clinical teams to support business objectives related to both product development and commercialization. The incumbent will bring deep expertise in clinical trial operations, a strong understanding of regulatory requirements, and technical knowledge specific to the relevant therapeutic area.Visa sponsorship: Boston Scientific will not offer sponsorship or take sponsorship of an employment visa at this time. Work mode: This is a hybrid position (in office minimum three days per week) to be located in Arbor Lakes, MN.Your responsibilities will include: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.Writes study protocols, protocol amendments, informed consents, project plans and timelines; stays abreast of current clinical practice by analyzing scientific data from literature and publications.Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines.Tracks development of and collaborates with the study team on all internal and external project materials, processes, manuals, plans, committees, vendors, study systems and all sponsor required regulatory submissions.Ensures the study team maintains a continuous state of audit readiness.In collaboration with the study team, leads the proactive identification, assessment, and management of clinical study risks and emerging trends.Facilitates communication between Sales & Marketing, Medical Affairs, Regulatory Affairs, R&D, 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 management.Interacts with regulatory agencies as needed and will use their scientific knowledge to provide directives to staff as well as study sites.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, Ethics Committees, etc.Required qualifications:Minimum 8 years related work experience with Bachelor's degree or 6 years with Master's degreeProven Clinical trial experience required (Sponsor or CRO)Advanced knowledge of Good Clinical Practices (GCP), ISO 14155 and FDA regulations governing the conduct of clinical trialsPrior or current experience working with external vendors and Contract Research Organizations (CRO)Preferred qualifications:Current or previous experience with medical device clinical trialsCurrent or previous experience with cardiovascular therapeutic areasProven ability to use in-depth knowledge of business nit functions and cross-functional group dependencies/relationshipsCompensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.