Clinical Study Manager

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.

**About This Role**:
Veranex has an exciting opportunity to join our team as a Clinical Study Manager. You will be part of a team working to improve lives globally through medical technology innovation. The Clinical Study Manager will be responsible for organizing clinical studies and local teams for clinical studies and ensuring studies are conducted in accordance with all applicable regulatory requirements, Good Clinical Practice (GCP), the study protocol and Standard Operating Procedures (SOPs), contract, and client’s expectations.

**What You Will Do**:

- Responsible for the day-to day management of project activities and deliverables.
- Serves as a liaison with stakeholders across all functional areas of the project
- Manages study budget and timelines
- Manages vendors, including the implementation and coordination of vendors scope of work (SOW)
- Responsible for the maintenance of clinical and regulatory files, with accurate and timely tracking and documentation
- Oversees the development of clinical reports supporting regulatory submissions
- Coordinates and supports execution of study projects, including site identification and initiation, ethics, and regulatory approvals, contracting, site budgeting, invoicing, site staff training, auditing, monitoring, and close-out activities
- Identifies and establishes the suitability of study investigators and their investigation sites and liaises with them to ensure compliance with all necessary study requirements, approvals, and agreements (e.g., financial and confidential)

**Qualifications**:
**Required skills**:

- Bachelors’ degree in health sciences or related discipline
- Minimum 2 years’ relevant work experience
- Excellent organizational, decision-making, and time management skills
- Strong knowledge of Good Clinical Practice (ISO 14155) and/or Good Study Practice (ISO 20916)
- Good knowledge of the European regulations MDR (EU 2017/745) and/or IVDR (EU 2017/746)
- Good written and oral communication skills in English
- Excellent attention to detail
- Ability to build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement
- Ability to work in a local office 1-3 days per week (hybrid)

**Preferred**:

- Strong ability to manage projects
- Good knowledge in risk assessment
- Good knowledge in statistics
- Other languages such as French, German and Italian a plus
- Good knowledge in cardiology
- IVD experience