Uppdrag tillsatt

Senior Clinical Research Monitor (Sr CRM) and study start-up specialist

  • Medtronic
  • Stockholm/Uppsala/Mälardalen
  • Publicerad: 14 juni, 2018
  • Fulltid

 

 

Medtronic are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. This is the ideal opportunity to join us, and be part of our commitment to the health of others. We know the combined resources of Medtronic will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career. Medtronic offers careers within an international, dynamical and high quality organization, where your opinion and initiatives are valued. One of the challenges you will face is managing your work within a very complex and demanding environment.

A successful Medtronic employee needs to be able to build strong relation- and partnerships across all Medtronic entities.  You should be an enthusiastic, driven, flexible, responsible, pro-active and communicative team player.

For the Medtronic Core Clinical Solutions (MC2) department and their monitoring group, we are now looking for a Senior Clinical Research Monitor (Sr CRM) for Sweden to be responsible for the startup activities in Sweden, but also with the ability to monitor studies across the Nordic countries.

 

As a Sr CRM at Medtronic You:

  • Will be responsible for the startup activities (site qualification visits, submission package, Patient Information Consent, ethic submissions, etc.) in Sweden, with close collaboration with the study teams.
  • Will be the responsible person for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, applicable regulatory standards, Ethic Committee policies and procedures, as well as business requirements. The role requires monitoring in all cross-business units at Medtronic, e.g. cardiovascular, neuromodulation, diabetes.
  • Should be able to work under minimal management, working closely with different study teams, site personnel, Medtronic field personnel and monitoring supervisors.
  • Should be able to take a leading role in managing all monitoring activities as performing site monitoring visits (remotely and on-site), documenting the visits and activities in CTMS, keep the sites up to date between the visits in accordance with the Monitoring Plan.
  • Will identify site needs and challenges, provide solutions, ideas and service to facilitate the clinical trial process.

We work according to applicable international and regional regulations, Good Clinical Practice Standards and Medtronic Standard Operating Procedures.

 

What the job is all about:

In order to meet the above mentioned responsibilities, you will collaborate with monitoring management and study team personnel towards securing Investigator compliance. You will understand the study protocol and accompanying background information (e.g., Investigator Brochure, etc.) and possess a working knowledge of disease state and investigational product, as well as an understanding of regulatory requirements. In addition, you will attend internal department, team, and investigator meetings as requested and adhere to all applicable Medtronic policies and procedures.

This is a field-based position, reporting to the Swedish Clinical Monitor Manager Nordic, Baltic & Poland.

 

To succeed in this position, you have:

  • A Bachelor’s Degree in life sciences, health related disciplines or nursing
  • 3 or more years of Clinical Research experience (preferably with Clinical Monitoring experience)
  • Expertise in GCP, ISO 14155 (preferably) and regulatory requirements in Sweden
  • Experience of the complete startup process and solid knowledge with Ethic Submissions & coordination in Sweden.
  • Business knowledge or experience within the medical/healthcare industry
  • A flexibility in terms of (inter)national travel, approximately 50-75 days/year

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 effectively pro-active on cross-functional teams with strong leadership skills. You are a good communicator and fluent in English and Swedish, both in writing and speaking.

As a Sr CRM at Medtronic you are field-based, but you will need to be able to be present at the Medtronic office in Kista, Stockholm 1-2 days a week to ensure optimal collaboration and communication with the closest team members and other colleagues. Ideally you therefore live in Stockholm/Uppsala or Mälardalen.

 

Apply for the job today!

In this recruitment Medtronic is collaborating with Moveup Consulting, so please send your CV in English to madeleine.krig@moveup.se

If you have any questions regarding this position, do not hesitate to contact Madeleine Krig, Moveup Consulting, at madeleine.krig@moveup.se or +46 730-26 22 63

We look forward to receiving your application and will handle applications continuously.

 

Genom att skicka din ansökan ger du också ditt samtycke till att vi lagrar dina personuppgifter, inklusive CV & personligt brev samt att vi äger rättigheten att dela dessa uppgifter med tredje part (vår uppdragsgivare). Samtycket kan du återkalla när du vill.

 

 

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