Senior Clinical Research Specialist works in line with strategic priorities of MC2 Study Solutions and 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.
Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
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.
Track 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.
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 5 years of relevant experience in clinical operations, management of clinical studies and project management
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
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 and 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 (French in particular)
Home based or office based
Willing to travel globally
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)