Senior Clinical Research Monitor (CRA) - Slovakia

Medtronic

Place of work
Bratislava
Contract type
full-time
Wage (gross)
2400.00 EUR/MONTH

Information about the position

Job description, responsibilities and duties

Careers that Change Lives

The Senior Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, applicable regulatory standards, Ethic Committee policies and procedures and business requirements.
The role requires monitoring in cross-business units, e.g. cardiovascular, neuromodulation and diabetes.
This position works under minimal supervision, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues.

A Day in the Life

As a Senior Clinical Research Monitors you will identify site needs, provide solutions to facilitate the clinical trial process assist in initial and ongoing site personnel trainings as required and identify and escalate protocol deviations, discrepancies in data, and non-compliance to study protocols.

Senior Clinical Research Monitors will work according to applicable international and regional regulations, Good Clinical Practice Standards and Medtronic Standard Operating Procedures. Senior Clinical Research Monitors might also provide input into final study site selection and be assigned to lead monitor responsibilities.

In order to meet these responsibilities a Senior Clinical Research Monitor:
• Collaborates with monitoring management and study team personnel towards securing Investigator compliance;
• Understands the study protocol and accompanying background information (e.g., Investigator Brochure, etc.);
• Possess a working knowledge of disease state and investigational product;
• Understands regulatory requirements;
• Attends internal department, team and investigator meetings as requested and adhere to all applicable Medtronic policies and procedures;
• Works within and actively promotes Medtronic’s Mission, corporate strategies, policies, procedures and Code of Conduct;
• Complies with Medtronic’s Finance and Legal policies and procedures;
• Will respond to both Internal and External Audit enquiries in a timely manner and ensure follow-up on Action Items to address Audit recommendations.

Information about the selection process

Your Answer

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Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)

Language skills

English - Upper intermediate (B2)

Personality requirements and skills

Must Haves

• Bachelor’s Degree in life sciences, health related disciplines or nursing
• 4+ years Clinical Research experience (at least two years of Clinical Monitoring experience)
• Expertise in GCP, and regulatory requirements in Slovakia
• Business knowledge or experience within the medical/healthcare industry
• Flexibility in terms of (inter)national travel (up to 80%)

Nice to Haves

• We are looking for a customer focused team player who is a clinical expert and experience working in a team/matrix environment, specialized in clinical site management, study monitoring and local regulations.
• Besides the ability to manage multiple tasks you dispose of good problem-solving skills, ability to work in a fast-paced environment and a high attention to detail and accuracy.
• You are used to take initiative and you demonstrate the ability to work independently
• You are a good communicator and fluent in Slovak and English, both in writing and speaking.

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Brief description of the company

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.
ID: 3506238  Dátum zverejnenia: 2.10.2018  Základná zložka mzdy (brutto) a ďalšie odmeny: 2400.00 EUR/MONTH