Boston Scientific
Senior Clinical Trial Manager
Boston Scientific, Marlborough, Massachusetts, United States, 01752
Senior Clinical Trial Manager
The Senior Clinical Trial Manager (CTM) will be responsible for the design, planning, execution and leadership of clinical studies worldwide for BSC's Coronary Therapies portfolio. The Senior CTM is responsible for leading cross-functional clinical teams in support of the organization's business objectives for product development and/or commercialization. The incumbent possesses technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within a given therapeutic area. This role follows a hybrid work model requiring employees to be in our Marlborough office at least three days per week at our BSC offices. Visa Sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. 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 will support 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. 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 IFUs and authorship of Clinical Evaluation documents (CES, CRBA, CDSR) for identification of harms and support of safety performance for product approval. Required qualifications: Minimum Bachelor's degree in a health-care related field Minimum 7 years of related work experience or an equivalent combination of education and work experience Minimum 3 years of experience managing clinical trials Proven experience with IDE clinical trials. Preferred qualifications: Preferred experience with interventional cardiology medical devices. Proven experience in managing the integration of clinical trials from acquired companies. Proven experience working with external vendors and Contract Research Organizations (CRO) Preference for a professional with a wide range of experience and expertise in a specialized technical or scientific field Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
The Senior Clinical Trial Manager (CTM) will be responsible for the design, planning, execution and leadership of clinical studies worldwide for BSC's Coronary Therapies portfolio. The Senior CTM is responsible for leading cross-functional clinical teams in support of the organization's business objectives for product development and/or commercialization. The incumbent possesses technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within a given therapeutic area. This role follows a hybrid work model requiring employees to be in our Marlborough office at least three days per week at our BSC offices. Visa Sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. 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 will support 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. 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 IFUs and authorship of Clinical Evaluation documents (CES, CRBA, CDSR) for identification of harms and support of safety performance for product approval. Required qualifications: Minimum Bachelor's degree in a health-care related field Minimum 7 years of related work experience or an equivalent combination of education and work experience Minimum 3 years of experience managing clinical trials Proven experience with IDE clinical trials. Preferred qualifications: Preferred experience with interventional cardiology medical devices. Proven experience in managing the integration of clinical trials from acquired companies. Proven experience working with external vendors and Contract Research Organizations (CRO) Preference for a professional with a wide range of experience and expertise in a specialized technical or scientific field Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.