Sr Clinical Research Specialist
Il y a 3 mois
**Careers that Change Lives**
In this exciting role as a Senior Clinical Research Specialist (Sr. CRS) in our Surgical Operating Unit (OU), you will have shared responsibilities in the execution and oversight of global clinical studies as an individual contributor, with specific responsibility managing study sites located in Europe. Your scope of work will include managing sub-projects (e.g., vendor set-up, data snapshot preparation, etc.) and deliverables (e.g., project plans, site training, etc.), working with a study team and stakeholders primarily in the United States and Europe to execute high-quality clinical research studies. Most of your time will be spent directly managing study sites in Europe - from start-up through closure - while adhering to policies and under the oversight of the Clinical Study Manager and Program Lead, using specialized knowledge and skills normally acquired through education and experience conducting clinical research studies. You will work with centralized, internal study support teams (e.g., Monitoring, Data Management, Safety, etc.) and may act as a mentor to colleagues or may direct the work of other lower-level professionals.
Our Surgical OU is Medtronic’s largest operating unit, bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. We approach the market with a unified approach from concept to commercialization, capitalize on our global commercial capabilities, and prove the power of our combined portfolio. With the Surgical OU, our General Surgical Technologies Business Unit has numerous implantable devices necessitating pre
- and post-market studies in Europe and/or the United States. Your position will support the Clinical Operations team in developing high-quality clinical evidence for hernia meshes and other such devices.
Preferred location(s): Remote from Europe
Ability to travel up to 50% (within Europe and international) during peak periods (site start-up), 10-20% during other periods.
**A Day in the Life**
- Contributes significantly to the planning and execution of clinical research studies under the oversight of a Clinical Study Manager in collaboration with centralized, internal study support teams (e.g., Monitoring, Data Management, Safety, etc.).
- Authors study documents and contributes to documents authored by Clinical Study Manager (e.g., Clinical Investigation Plan).
- As site manager, oversees and resolves operational aspects of clinical study sites in conjunction with country-specific monitor(s) and global study team and in accordance with Medtronic standard operating procedures (SOPs), good clinical practice (GCP), European Medical Device Regulation (MDR) and other specific country or regional regulations.
- Represents Medtronic clinical research within a country / region to local customers and authorities as needed for clinical study execution. Builds and maintains optimal relationships and effective collaborations with internal and external parties in relation to these customers.
- Contributes to clinical supply operations, site, and vendor selection and/or management.
- Coaches and reviews the work of lower-level specialists; may manage sub-projects / processes as delegated by Clinical Study Manager.
**Must Haves**
- Bachelor’s Degree with 4+ years of clinical research experience
o
_OR _
- An advanced degree with 2+ years of clinical research experience
**Nice to Haves**
- Degree in engineering, life sciences, or related medical/scientific field.
- 5+ years’ experience managing or supporting clinical trials within Medtronic or medical device industry.
- Fluent in English and French
- Located in France
- Experience working on a European pre-market study team managing multiple clinical research sites with proven results in study execution.
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials, such as CFR 812, 50, 54, and ISO14155:2020
**We Offer**
We offer a competitive salary and benefits package to all our employees:
- Flexible working environment
- Annual Incentive Plan % depending on company results.
- Pension scheme and group discount on healthcare insurance
- Training possibilities via Cornerstone/Harvard Manage Monitor/Skills Lab
- Employee Assistance Program and Recognize (Our global recognition program)
**Our commitment**
Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute.
We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact.
Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologie
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