Clinical Trial Manager, EP at Boston Scientific Corporation Malaysia

Machelen, East Flanders, Belgium -

Full Time

Start Date

Immediate

Expiry Date

26 Feb, 26

Salary

0.0

Posted On

28 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trials, Project Management, Regulatory Compliance, Clinical Strategy, Scientific Expertise, Vendor Management, Cross-Functional Leadership, Data Analysis, Medical Devices, Electrophysiology, Atrial Fibrillation, Communication, Team Collaboration, Budget Management, Clinical Documentation, Stakeholder Engagement

Industry

Medical Equipment Manufacturing

Description

Additional Locations: Belgium-Diegem 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 is responsible for the design, planning, execution, and leadership of clinical studies and clinical programs worldwide as well as leading cross-functional clinical teams in support of the organization's business objectives for product development and/or commercialization. The Clinical Trial Manager possesses a technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within a given therapeutic area. This global role is part of the electrophysiology (EP) division, and offers weekly hybrid working (in office, minimum three days per week) from our Brussels office or any other BSC hub office at the sole discretion of Boston Scientific. Your responsibilities will include: Authors key clinical study documents and project deliverables, including study protocols, protocol amendments, informed consents, and study plans. Provides leadership in the development of clinical strategy and trial design by conducting meetings with the appropriate stakeholders, departments and individuals to obtain feedback/direction. Provides leadership and scientific expertise throughout the development and implementation of local or global clinical studies, including studies executed by a CRO. May author or assist in the writing of scientific abstracts and papers for publication by evaluating scientific literature, analysing scientific data and staying up to date of current clinical practice. Provides leadership in the clinical support of product approval, indication expansion, and claim support, and mandated post-market requirements. Partners with Regulatory Affairs and agencies to facilitate submissions and communications, leveraging scientific expertise to guide internal teams and investigational sites, ensuring compliance and successful regulatory outcomes. 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 Leadership (BPT/PIB, etc.). May manage clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines. Presents scientific data by communicating accurate, concise 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. What are we looking for in you: A bachelor's degree in a healthcare related field. Approximately 5 years of related work experience or an equivalent combination of education and work experience within clinical trials. Approximately 3 years' experience managing clinical trials. Professional working proficiency language skills (or above) in English. Preferred qualifications: Experience in leading clinical trials with medical devices desired, specifically in the field of electrophysiology or cardiology. Atrial fibrillation/flutter ablation knowledge is advantageous. Can use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships. Proven experience working with and managing external vendors. What we can offer to you: A company with a purposeful mission. Attractive benefits. A team-orientated company culture. International opportunities. Permanent position. A global role. Hybrid working. Requisition ID: 618592 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) isn't just business, it's personal. And if you're 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!

Responsibilities

The Clinical Trial Manager is responsible for the design, planning, execution, and leadership of clinical studies and clinical programs worldwide. This role includes authoring key clinical study documents and providing leadership in clinical strategy and trial design.