Clinical Trial Manager, EP

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. This incumbent 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.

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 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 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 (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.
• 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.
• May author scientific abstracts and/or publications.
• 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.

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 investigational 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.