Clinical Trial Manager - Cardiology/EP
Location
Marlborough, MA | United States
Job description
Additional Location(s): N/A
Diversity - 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 Clinical Trial Manager will be responsible for the design, planning, execution and leadership of clinical studies and clinical programs worldwide for our Watchman 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 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 DFUs and authorship of Clinical Evaluation documents (CES, CRBA, CDSR) for identification of harms and support of safety performance for product approval.
Required qualifications:
- Minimum of a Bachelor’s degree
- Minimum of 5 years of related work experience or an equivalent combination of education and work experience.
- Minimum of 3 years of Clinical and trial experience required
Preferred qualifications:
- Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/ relationships
- Ability to apply comprehensive technical knowledge of Cardiology and/or Electrophysiology 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
- Experience working with external vendors and Contract Research Organizations (CRO)
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