EMEA Senior Clinical Trial Manager Job Details

EMEA Senior Clinical Trial Manager

Work mode: Hybrid

Onsite Location(s): le-de-France, 75, FR

Additional Locations: France-le-de-France; Belgium-Diege; Germany-Dsseldorf; Italy-Milan; Spain-Madrid; United Kingdom-Hemel Hempstead

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, well give you the opportunity to harness all thats 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, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions.

The Senior Clinical Trial Manager will be responsible for the design, planning, execution, and leadership of clinical studies and clinical programs worldwide for our Watchman portfolio. This role is responsible for leading cross-functional clinical teams in support of the organization's business objectives for product development and/or commercialization. This incumbent possesses a technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within a given therapeutic area.

This is a hybrid position (in-office minimum three days per week) with the flexibility to be in one of our EMEA offices with the preference to Diegem. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

• 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, 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 and budgets 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.

• Minimum of a Bachelors degree or equivalent experience needed.
• Minimum of relevant and related 8 years of work experience or an equivalent combination of education and work experience.
• Minimum of 5 years of Clinical and trial experience required.

• 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.
• Proven experience working with external vendors and Contract Research Organizations (CRO).

Interested? Please apply online with your CV in English.

Requisition ID: 614362

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isnt just business, its personal. And if youre a natural problem solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

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