Boston Scientific Clinical Trial Manager 

United States, Massachusetts, Marlborough 

650045459

The Clinical Trial Manager will be responsible for the design, planning, execution and leadership of clinical studies and clinical programs worldwide for BSC’s Coronary Therapies portfolio. 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.
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:

• Bachelor’s degree and 5+ years of related work experience or an equivalent combination of education and work experience
• Clinical trial experience required
• Experience working with external vendors and Contract Research Organizations (CRO)

Preferred Qualifications:

• Experience with investigational device clinical trials
• Experience with interventional cardiology and/or heart failure therapeutic areas
• Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships
• Ability to apply comprehensive technical knowledge of Interventional Cardiology to resolve complex issues in creative ways
• Preference for a professional with a wide range of experience and expertise in a specialized technical or scientific field

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.