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Arbetsbeskrivning
Location: Södertälje (Sweden)
As a Country Head you will lead the Site Management & Monitoring (SMM) who is part of Clinical Operations in the Global Medicines Development (GMD) function and executes and delivers clinical studies. Your responsibility is to lead, develop and give guidance to them to enable the local high-quality performance, productivity and delivery of committed clinical studies in the area. As a Country Head you will reports to the Regional Director SMM Europe.
As a Country Head you will have the responsibility for the local clinical study strategy planning and execution and for delivery of committed clinical studies according to agreed resources, timelines, budget and quality and in compliance with regulatory requirements and AstraZeneca procedural documents.
You will ensure appropriate resourcing and skills management within own and reporting lines. You will also be accountable that study sites are identified, site qualifications performed, set up (as appropriate), initiated, monitored, closed and documentation archived.
Main Accountabilities/Responsibilities
* Drives, secures and monitors clinical study execution in the Nordic area
* Accountable for quality, reliability and productivity are in accordance with global, regional and Nordic objectives.
* Accountable for effective resource allocation of the different functions within SMM to ensure proper delivery of committed studies, including identification of any need for in/outsourcing to CRO
* Accountable for MC related resource effectiveness and productivity
* Accountable for assigned budget
* Accountable for building a visionary and productive local SMM Management Team
* Provide expertise and guidance to support direct reports with proactive problem/risk identification, solution building and issues resolution to facilitate achievement of objectives on time and to appropriate quality.
* Promote and encourage innovation and creativity by bringing suggestions/good examples to departmental leadership
* Act as main point of contact for SMM Region Europe and CROs in outsourced studies
* Maintain a constructive and productive collaboration with the SMM Europe region and related global functions
* Ensure relevant education and training of staff
* Ensure compliance with Regulatory and Patient Safety regulations and processes
* Ensure a good and well-functioning cooperation with local MC President, Medical Affairs, Regulatory Affairs, Medical Evidence functions and other local support functions
* Contributes to building a visionary and productive Nordic Medical Management Team
Minimum Requirements
* Bachelor of Science degree in related discipline, preferably in medical, biological, or health related sciences, or equivalent qualification
* Minimum 5 years experience in the pharmaceutical industry and demonstrated drug development and clinical project management capability and experience
* Preferably 1- 3 years experience as line manager in the pharmaceutical industry and in an international environment
* Comprehensive knowledge of the drug development process
* Very good knowledge of spoken and written English and preferably also in Swedish
* Good understanding of the therapeutic areas related to AZ products
* Good understanding and knowledge of relevant applicable regulations
* Ability to understand integrated worldwide and regional delivery needs
* Ability to travel nationally and internationally
Information
For more information about the position please contact: Patryk Mikucki, Regional Dir SMM Europe
Welcome with your application no later than March 23, 2018.
Interviews will be held by recruiting manager together with other senior representative from SMM Leaders.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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