Sr. Clinical Research Specialist – Cranial and Spinal Technologies

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Careers that Change Lives

Help lead the effort to create global strategies for worldwide medical device market approvals, expanded indications, and data generation to support life-restoring products. Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentoring, and guidance you need to own your future success. Join us for a career that changes lives.

A Day in the Life

In this exciting role as a Senior Clinical Research Specialist (Sr. CRS), you will contribute to planning, design, development and execution of clinical studies and clinical projects to generate data in line with global regulatory requirements and business strategies. You will independently oversee study/project with little supervision and contribute to the completion of work group/team objectives, through building relationships and consensus to reach agreements on assignments. We are looking for someone with growth potential, strong customer relationship focus, ability to influence others, ability to understand and evaluate data, and represent the clinical function on cross-functional teams. This position is accountable for driving execution and oversight of all study/project related activities, which may include:

  • Managing the study/project strategy (e.g. Investigational Plan), budget, resources, and timelines

  • Leading the clinical core team in coordinating activities, such as collecting, reconciling, and reporting clinical data for the study/project

  • Ensuring quality by maintaining compliance, reviewing adverse events and device complaints, reviewing audit reports, and implementing corrective actions (as applicable)

  • Supervising training of investigators, study/project site staff, and Medtronic clinical staff

  • Building trusting relationships with Surgeons and Clinical Research Coordinators located at hospitals/sites/clinics.

  • Coaching and reviewing the work of lower level specialists for projects that manage

Responsibilities may include the following and other duties may be assigned:

  • Part of a team that conducts clinical studies/projects of or for products that have been determined to satisfy a medical need and/or offer a commercial potential

  • Design, plan, develop and execute clinical studies/projects

  • Prepares and authors protocols, project plans and data record forms

  • Works with the team to interpret study/project results in preparation for new device application, expand product indication, and/or gather data to support research and development analyses

  • Resolves operational aspects of clinical trials in accordance with standard operating procedures (SOP), GCP, ISO 14155 and specific country regulations

  • Prepares and maintainsstudy/project budgets

  • Helps to set the milestones of a clinical study/project in compliance with applicable clinical and regulatory standards

  • Accountable for overall study/project site activation and subject tracking

  • Has complete understanding of subject data and study/project trends, as applicable

  • Builds and maintains optimal relationships and effective collaborations with various internal and external parties

  • Makes improvements to solve problems and provides in-depth analysis and recommendations on process improvements

Do you have what it takes:

  • Bachelor or Master degree in Life Sciences

  • 4-5 years' experience with direct support to clinical studies or similar

  • Strong networking skills

  • Able and willing to strictly follow procedures/SOP's, regulations and guidelines

To be successful in this role you recognize yourself as a:

Customer focused team player who has an expertise in developing and executing international multi-center studies and or/clinical projects, who is familiar with project management tools and techniques. You are very familiar with clinical study principles, GCP and ISO 14155 and regulatory compliance guidelines for clinical trials. Previous experience as a CRA or working in the field is a nice to have.

You dispose good problem-solving skills; have a high attention to detail, and a sense of urgency. You are outgoing, pro-active, process-oriented and have an all-inclusive attitude towards stakeholders. You are an excellent communicator and fluent in English, both in writing and speaking. Some (inter)national travel (around 20%) is part of the job.

Your answer
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About Medtronic
As a global leader in medical technology, services and solutions, Medtronic improves the health and lives of millions of people each year. We believe our deep clinical, therapeutic and economic expertise can help address the complex challenges - such as rising costs, aging populations and the burden of chronic disease - faced by families and healthcare systems today. But no one can do it alone. That’s why we’re committed to partnering in new ways and developing powerful solutions that deliver better patient outcomes.

Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 86,000 people worldwide, serving physicians, hospitals and patients in over 155 countries. With our European Operations Center for Distribution and Shared Services in Heerlen, the Bakken Research Center in Maastricht, our manufacturing facility in Kerkrade, and the Dutch sales office in Eindhoven, Medtronic Netherlands has more than 2,000 employees.

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Additional Information
  • Posting Date: Dec 28, 2020
  • Travel: Yes, < 25 % of the Time
Type vacature:
Intern

Vaardigheden

  • Er is geen minimale opleiding vereist
  • Voor deze functie is er geen minimale werkervaring vereist
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