Principal Clinical Research Specialist
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Monthly Salary:
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
Peripheral Vascular Health therapies are a vital part of Medtronics vascular portfolio addressing conditions such as Peripheral and Carotid Disease End Stage Renal Disease Peripheral Embolization and Superficial and Deep Venous Disease. Medtronic leads in the Superficial Venous and Drug Coated Balloon markets providing lifesaving and life-enhancing therapies to millions of patients worldwide. The company values a diverse and inclusive workforce actively seeking employees who are patient-focused passionate and bring diverse perspectives to drive innovation.In this role you are expected to lead the development and execution of clinical studies as well as oversee clinical strategies to evaluate product safety performance and effectiveness post-market release. You will manage complex clinical studies/projects ensuring milestones are met while complying with regulatory standards and Medtronic internal requirements. Additionally you are responsible for project management site management activities as needed and providing strategic oversight and direction to personnel supporting your trials. This role requires independent work and managing trials of high complexity which may also be global in scope. You will report directly to the Senior Clinical Research Manager and will primarily work from the office with occasional travel requiredup to 15%.
Responsibilities may include the following and other duties may be assigned:
- Design and Oversight of Clinical Studies: Oversees designs plans and develops clinical evaluation research studies including protocol and patient record form preparation
- Execution of Clinical Trials: Manages operational aspects of registered and non-registered clinical trials ensuring compliance with SOPs GCP and country regulations and may handle clinical trial budgets
- Results Interpretation and Reporting: Oversees and interprets clinical investigation results for product applications and prepares status reports on projects and budgets
- Team Leadership: Provides direction to cross-functional teams (e.g. site managers monitoring safety statistics) and serves as a liaison between study teams leadership and program management
- Local and Regional Collaboration: Represents Medtronic within the region/country builds relationships with local customers and authorities and drives evidence dissemination and awareness
- Cross-Functional Collaboration: Works closely with medical affairs regulatory marketing and other teams to refine trial designs and communicate updates
- Project Management: Develops and improves project management processes tools and best practices to address issues and meet productivity quality and client satisfaction goals
Required Knowledge and Experience:
- Bachelors degree with 7 years or Masters/PhD with 5 years of clinical research experience in developing and executing clinical studies
- Degree in engineering life sciences or related medical/scientific field with experience in Medtronic or medical device industry clinical strategies study design and therapies like Peripheral Venous or Carotid
- Experience in global study teams regulatory compliance (GCP ISO FDA MDR etc.) and understanding of biostatistics and trial design
- Proficient in project management techniques/tools (MS Project PMP certification Green Belt certification) with expertise in both theoretical and practical aspects
- Skilled in MS Office applications (Excel PowerPoint Word) R&D experience and good clinical practice guidelines
- Strong communication skills fluent in English (written and spoken) with proven ability to build networks and collaborate effectively
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here
Required Experience:
Staff IC
Key Skills
- Laboratory Experience
- Spss
- Data Collection
- Genetics
- R
- Research Experience
- Statistical Software
- Cell Culture
- Molecular Biology
- Microscopy
- Research Laboratory Experience
- Western Blot
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 excit ... View more
