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Clinical Research Manager EE
Medtronic
Place of work
Bratislava
Bratislava
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
Based in any of following locations: Budapest / Prague / Bratislava / Bucharest.
Careers that Change Lives
Would you like to work for a rapidly growing international healthcare company?
Day in the Life
Principal responsibilities of Clinical Research Manager:
* People management - leads and manages the team of individual clinical professionals and supports staff in his/her region.
* Internal relations - assures successful & timely execution of assigned clinical programs, consistent with clinical plans and applicable regulations and policies.
* External relations:
- builds and maintains a strong network with key-opinion leaders in the region.
- acts as interface between local customers / authorities / KOLs / local Clinical Affairs and relevant stakeholders at Medtronic.
* Quality, regulatory and expertise :
- assures that clinical studies meet highest scientific, statistical, quality and ethical standards; maintains professional scientific, technical and clinical expertise.
- has working knowledge of European Medical Device regulations, clarifies the interpretation with Regulatory Affairs Department and other regulatory bodies in European countries when necessary.
* Execution:
- negotiates contents and formats of clinical plans, clinical protocols and clinical reports with relevant stakeholders within Medtronic.
- ensures appropriate resources and priorities are maintained for the various projects assigned to the region/country.
- for global studies (SBU/BU studies): Responsible for investigator nomination, interacts with investigators to facilitate the study execution.
- for local studies: Responsible for investigator's selection and agreements.
- partners with cross functional stakeholders to nominate for site selection to SBU/BU clinical (marketing, MC2 (MCO & RCC), Office of Medical Affair.
* Position requires substantial international travel.
Careers that Change Lives
Would you like to work for a rapidly growing international healthcare company?
Day in the Life
Principal responsibilities of Clinical Research Manager:
* People management - leads and manages the team of individual clinical professionals and supports staff in his/her region.
* Internal relations - assures successful & timely execution of assigned clinical programs, consistent with clinical plans and applicable regulations and policies.
* External relations:
- builds and maintains a strong network with key-opinion leaders in the region.
- acts as interface between local customers / authorities / KOLs / local Clinical Affairs and relevant stakeholders at Medtronic.
* Quality, regulatory and expertise :
- assures that clinical studies meet highest scientific, statistical, quality and ethical standards; maintains professional scientific, technical and clinical expertise.
- has working knowledge of European Medical Device regulations, clarifies the interpretation with Regulatory Affairs Department and other regulatory bodies in European countries when necessary.
* Execution:
- negotiates contents and formats of clinical plans, clinical protocols and clinical reports with relevant stakeholders within Medtronic.
- ensures appropriate resources and priorities are maintained for the various projects assigned to the region/country.
- for global studies (SBU/BU studies): Responsible for investigator nomination, interacts with investigators to facilitate the study execution.
- for local studies: Responsible for investigator's selection and agreements.
- partners with cross functional stakeholders to nominate for site selection to SBU/BU clinical (marketing, MC2 (MCO & RCC), Office of Medical Affair.
* Position requires substantial international travel.
Employee perks, benefits
Do you consider you have the right experience for a regional Clinical Research Manager role? If yes, then send us your resume and enter the recruitment process right away!
Join Medtronic where we appreciate your talent, experience and passion for your work. You can count on professional and personal development, exciting challenges and a dynamic environment.
This is an exciting opportunity where, as a regional Clinical Research Manager you will take responsibility for all clinical research activities in Medtronic's divisions, including communication with Key Opinion Leaders and Investigators, in your regional scope. Reporting to this function will be all clinical affairs professionals and related support staff in the region; you will report to the Regional Clinical Leader.
In return, we will provide you with world-class training, development opportunities, and the opportunity to work in a varied and challenging role. Our offer package will include a competitive salary and other great benefits.
For this regional role you will be expected to be located in any of those: Budapest, Hungary / Prague, Czech Republic / Bratislava, Slovakia / Bucharest, Romania.
Join Medtronic where we appreciate your talent, experience and passion for your work. You can count on professional and personal development, exciting challenges and a dynamic environment.
This is an exciting opportunity where, as a regional Clinical Research Manager you will take responsibility for all clinical research activities in Medtronic's divisions, including communication with Key Opinion Leaders and Investigators, in your regional scope. Reporting to this function will be all clinical affairs professionals and related support staff in the region; you will report to the Regional Clinical Leader.
In return, we will provide you with world-class training, development opportunities, and the opportunity to work in a varied and challenging role. Our offer package will include a competitive salary and other great benefits.
For this regional role you will be expected to be located in any of those: Budapest, Hungary / Prague, Czech Republic / Bratislava, Slovakia / Bucharest, Romania.
Information about the selection process
Is this the position you were waiting for? Then please apply directly via the apply button!
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
University education (Master's degree)
Postgraduate (Doctorate)
Language skills
English - Upper intermediate (B2)
Personality requirements and skills
Must Haves:
* Master's Degree in relevant biomedical field (Medicine, Biomedical Engineering, Medical Physics, Medical Biology, Health Sciences, etc).
* 8 years experience directly supporting clinical research or similar experience in a medical/scientific area.
* At least 2-3 years experience managing people, budgets and clinical studies, ability to effectively lead remote teams.
* Strong project management skills, ability to manage multiple tasks, ability to work effectively on cross-functional teams.
* Expertise with GCPs and regulatory compliance guidelines for clinical trials.
* Knowledge of clinical and outcomes research study design.
* Proficient knowledge of medical terminology.
* Good problem-solving skills, decisive.
* Solid interpersonal and judgement skills.
* Advanced written and oral communication skills.
* Finance and budgeting knowledge.
* English language capabilities.
* Demonstrated ability to work in a matrix organization.
* Willingness to travel (up to 50% time).
* Master's Degree in relevant biomedical field (Medicine, Biomedical Engineering, Medical Physics, Medical Biology, Health Sciences, etc).
* 8 years experience directly supporting clinical research or similar experience in a medical/scientific area.
* At least 2-3 years experience managing people, budgets and clinical studies, ability to effectively lead remote teams.
* Strong project management skills, ability to manage multiple tasks, ability to work effectively on cross-functional teams.
* Expertise with GCPs and regulatory compliance guidelines for clinical trials.
* Knowledge of clinical and outcomes research study design.
* Proficient knowledge of medical terminology.
* Good problem-solving skills, decisive.
* Solid interpersonal and judgement skills.
* Advanced written and oral communication skills.
* Finance and budgeting knowledge.
* English language capabilities.
* Demonstrated ability to work in a matrix organization.
* Willingness to travel (up to 50% time).
Advertiser
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.
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: 3246925
Dátum zverejnenia: 19.11.2017
2017-11-19
lokalita: Bratislava Pozícia: Clinical Data Manager, Clinical Research Associate Spoločnosť: Medtronic