Associate Director Study Management, Early Clinical Development
AstraZeneca / Undersköterskejobb / Göteborg
2017-06-30
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➡️ Klicka här för den senare publicerade platsannonsen "Associate Director Study Management, Early Clinical Development" (publicerad 2018-12-10) ⬅️
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hela Sverige Are you committed and would like to be working in the Early Clinical Development? Then this is a great opportunity for you to be part of an international environment.
We are looking for an Associate Director Study Management to AstraZeneca. You would be working within the RIA Translational Medicine Unit in Early Clinical Development that will be placed in Gothenburg, Sweden. As Associate Director Study Management you will influent the team, planning and leading the delivery of all AstraZeneca sponsored and Early Clinical Development (ECD) led, internally as well as externally.
As Associate Director Study Management, you will have the main responsible for the overall delivery of the clinical studies to time, cost and quality and is the coordinator and leader of the clinical study team. You will be working closely with the Director Scientific Project Management and the Medical Science Director and will provide operational and feasibility input into design of the clinical studies. The exact accountabilities will differ depending on the exact nature of the clinical programme, you may be required to fulfil some clinical study coordination tasks or take on clinical leadership tasks depending on project/delivery model.
You will work in an exciting environment and join a team of 17, including medically qualified physicians, medical scientists, clinical project as well as study leaders. We have close links with the preclinical research organisation (RIA iMed) and provide clinical input and plans for all small molecules in the early development portfolio and work closely with translational science and personalised healthcare. Our aim is to move treatment of Respiratory disease beyond symptom control to disease modification and cure - we have a number of assets in the pipeline so this is a very exciting time in Respiratory drug development at AstraZeneca.
Main Duties and Responsibilities
* Plan and Lead the delivery and reporting of all components of an AstraZeneca sponsored ECD led clinical study (ies) to time, quality, budget, project standards, company quality standards, and scientific requirements from Study Specifications/synopsis (SS) through CSR.
* Leader of the study delivery team for AstraZeneca sponsored ECD led clinical studies
* Liaise with Global Medicines Development Clinical Operations group to identify and resolve operational feasibility issues, and facilitate study start-up activities
* Forecasting and day-to-day management of study timelines, budget, materials and development of detailed study level plans and feasibility assessment
* Lead and implement globally agreed study level process and technology for ECD led clinical studies
* Develop & manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate
* Lead preparation and delivery of study documents (e.g. Protocols/amendments, documents detailing study delivery data management activities, etc.)
* Track and manage to agreed study timelines, budget, and resource and ensure the update of appropriate systems (e.g. IMPACT, OPAL, )
* Plan, lead and ensure appropriate training is achieved at Investigator/monitor meetings for AstraZeneca sponsored ECD led clinical trials
* Lead and optimize the performance of study delivery teams ensuring GCP compliance, including provision of timely and accurate performance feedback for study team members to the appropriate skill centre managers
* Provision of study level reports for AstraZeneca sponsored ECD led clinical trials
Essential Requirements
* University degree in related discipline, preferably in medical or biological science, or discipline associated with Clinical Research
* At least 5 years of experience in leading studies/programmes in early clinical development
* Experience of working with and delivering through strategic partners and 3rd party vendors
* Knowledge of high degree of autonomy, flexibility and ability to interact directly with senior medical and project leadership
* Proven leadership experience, people and project
* Project Management experience within the context of Clinical Drug Developmen
Desirable Requirements
* Programme management qualification
* Experience in variety of organisations and countries
If you are interested, apply now!
For more information about the position please contact Malin Aurell +46 31 7761449 or +46 733 542018
Welcome with your application no later than 7 August, 2017.
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.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2017-06-30ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2017-08-11
Ange följande referens när du ansöker: R-010005
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
daniela.bourquez@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 3584479
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