Clinical Research Specialist

**CLINICAL RESEARCH SPECIALIST** **Careers that Change Lives** Clinical Research Specialist works in line with strategic priorities of MC2 Study Solutions. Clinical Research Specialist collaborates with involved stakeholders (internal and external) in realizing the clinical evidence strategy throughout the clinical studies, executes clinical studies fully complying with Medtronic SOPs and applicable regulations, managing/coordinating all the other functions. **A Day in the Life** Responsibilities may include the following and other duties may be assigned. - Oversees, designs, plans and develops clinical evaluation research studies. - Prepares and authors protocols, patient record forms and other documents applicable for sponsored clinical studies. - Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. - Formulates the applicable Clinical Study Reports. - Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, may prepare clinical trial budgets. - May be responsible for clinical supply operations, site and vendor selection. - May establish and manage Steering Committee and Investigators meetings. - May represents Medtronic from a clinical research respective within the country / region and may also collects feedback from local customers and authorities. - Builds and maintains optimal relationships and effective collaborations with various internal and external stakeholders. - Tack study execution according to agreed KPIs, milestones and budget. - Applies a risk management approach to identify and mitigate potential threats to the successful conduct of clinical studies. **Qualifications - External** **Must Haves** - University Masters or Bachelor’s degree in relevant technical, science or biomedical field. - General knowledge of ‘Good Clinical Practice’ and applicable regulations and standards (e.g. EU MDR, ISO 14155, etc) - Minimum of 3 years of relevant experience in clinical operations - Experience in management of clinical studies and project management - Knowledge of MDT products/ therapies (matured experience in at least one therapy) - Fluent English, both in writing and in speaking - Good knowledge of Microsoft Office **Nice to Haves** - Outstanding interpersonal and communication skills - Ability to multitask & to effectively deal with competing business priorities - Customer focus - Ability to think in the bigger picture and have global perspective - Strong problem solving & influencing skills - Demonstrated ability to work effectively on cross-functional teams - Demonstrated ability to work in a matrix organization - Project management and scientific writing skills - Ability & comfortable to ensure strict adherence to regulations - Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues - Additional languages knowledge is welcome **Additional Info**: - Location: EMEA - Home based or office based - Willing to travel globally **About Medtronic** Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America) **Travel**: Yes, < 25 % of the Time