Senior Clinical Trial Manager, Europe

**Work mode**:Remote in Country

**Onsite Location(s)**:Voisins le Bretonneux, France

**Additional Locations**: Remote

**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 Sr. Clinical Trial Manager will be responsible for the design, planning, execution and leadership of clinical studies and clinical programs worldwide for BSC’s Structural Heart Valves (SHV) 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 the pertinent therapeutic area.
- This permanent role offers remote work and is to be based in Europe.

**Your responsibilities will include**:

- 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.
- Writes study protocols, protocol amendments, informed consents, project plans and timelines; stays abreast of current clinical practice by analysing scientific data from literature and publications.
- Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines.
- Tracks development of and collaborates with the study team on all internal and external project materials, processes, manuals, plans, committees, vendors, study systems and all sponsor required regulatory submissions.
- Ensures the study team maintains a continuous state of audit readiness.
- In collaboration with the study team, leads the proactive identification, assessment, and management of clinical study risks and emerging trends.
- Facilitates communication between Sales & Marketing, Medical Affairs, Regulatory Affairs, R&D, 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 management.
- Interacts with regulatory agencies as needed and will use their scientific knowledge to provide directives to staff as well as study sites.
- 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, Ethics Committees, etc.

**What are we looking for in you**:

- 8+ years related work experience with a bachelor’s degree, or 6+ years with master’s degree.
- Clinical trial experience required (Sponsor or CRO).
- Intimate knowledge of Good Clinical Practices (GCP) and ISO 14155 guidelines for governing the conduct of clinical trials. Additional knowledge of FDA guidelines is beneficial.
- Experience working with external vendors and Contract Research Organizations (CRO).
- Experience with medical device clinical trials.
- Experience with cardiovascular therapeutic areas is beneficial.
- Can utilise in-depth knowledge of business unit functions and cross-functional group dependencies/relationships.

**What we can offer to you**:

- A company with a purposeful mission.
- Attractive benefits.
- A team-orientated company culture.
- International opportunities.
- Permanent position.
- Remote working.

**Requisition ID**:600710

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