Clinical Operations Manager
Getinge AB / Inköpar- och marknadsjobb / Solna
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Visa alla inköpar- och marknadsjobb i Solna,
Sundbyberg,
Stockholm,
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hela Sverige Visa alla jobb hos Getinge AB i Solna,
Örebro,
Växjö,
Göteborg,
Halmstad eller i
hela Sverige In this position you will be responsible for directing clinical operations activities supporting Getinge Group anaesthesia and ventilation products.
Among the main responsibilities and tasks of the Clinical Operations Manager will be:
Strategic Planning & Technical Documentation
• Develops good working knowledge of Getinge Group investigational and registered medical devices and related clinical applications
• Supports risk management processes including Clinical Evaluations, Post Market Follow-up studies and registries.
• Assists in assessment of new business opportunities and related questions on clinical trial design strategy and development.
Medical & Clinical Research
• Provides clinical expertise input on essential study documentation and related processes including e.g. protocols, informed consent forms, training materials, work instructions, study management plans and manuals as well as clinical study reports.
• Participates in R&D development teams in providing clinical operations input for new and continuing product development projects.
• Participates in evaluating Investigator-Initiated Study (IIS) proposals. Coordinates communication and manages activities related to the IIS program and physicians/institutions requesting collaboration.
• Partners with external subject matter experts and project collaborators/vendors to ensure proper conduct of activities within the Clinical and Medical Affairs department.
• Coordinates and drives activities through the lifecycle of clinical studies ensuring targets are met according to timelines, budgets and quality expectations.
• Applies good organization and project management skills to implement operationally sound clinical investigations carried out in human subjects for regulatory submission purposes.
• Demonstrates good working knowledge of clinical investigation and risk management related ISO, MEDDEV, ICH, CFR standards to assure compliant Getinge clinical operations activities.
Quality Systems and Related Duties
• Supports the Quality System by complying with all reporting requirements.
• Promotes a work environment of continuous improvement that supports Getinge's Quality Policy, Quality System and the appropriate regulations.
• Stays current with and permanently documents all required training.
• Adheres to good clinical practice, Getinge's clinical processes and related regulatory requirements for clinical study conduct, timely safety event review and accurate reporting.
Other
• Contributes to the development and standardization of templates and related standard operating processes.
• Contributes and supports education and training programs.
The position is located at the Getinge manufacturing site in Solna. The role requires occasional international travel, approximately 30% of the time. You will be reporting to the Head of Clinical Affairs - Acute Care Therapies (ACT) in the USA.
We are looking for candidates with the following experience:
• At least Bachelor's degree or equivalent, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Ideally plus a Master's degree in Clinical Research.
• Knowledge of Computer literacy, ideally familiar with EndNoteTM and MS Project.
• Minimum of 3 years of experience with a medical device company, CRO or as a consultant.
• Minimum of 6 years of relevant experience in managing clinical study and development activities.
• Strong clinical operations and project management skills as well as good clinical practice knowledge.
• Expertise in critical path activities toward product commercialization.
• Familiar with medical device development process and related regulatory requirements and laws.
• Experience in authoring and review of clinical study or scientific reports.
As a person you are a committed and driven team-player in a dispersed team around the globe. You have an open mindset with outstanding ability to communicate explicitly and clearly with various stakeholders and possess excellent presentation skills with particular focus on key messages. To succeed in this position, you need to be able to successfully manage multiple competing priorities, have a good sense of structure and outstanding organizational skills. You are proactive with independent problem solving abilities and you pay attention to detail. Additionally, you need to have the willingness to travel and a genuine interest in distinct cultural environments.
At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope - just to name a few.
A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.
Publiceringsdatum2017-05-08Så ansöker duSista dag att ansöka är 2017-06-04
KontaktDenise Webber
denise.webber@getinge.comFöretagGetinge AB
AdressGetinge AB
Box 8861
40272 Göteborg
KontorsadressLindholmspiren 7A
Jobbnummer 3483496
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