Associate Director Study Management, Early Clinical Development
AstraZeneca / Apotekarjobb / Göteborg
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hela Sverige AstraZeneca is looking to recruit an Associate Director Study Management (ADSM) to join the Respiratory, Inflammation and Autoimmunity (RIA) Translational Medicine Unit within the Early Clinical Development (ECD) function. The position is located at AstraZeneca's vibrant R&D site in Gothenburg, Sweden where most of the early respiratory project teams are placed.
ECD is a dedicated clinical scientific resource for AstraZeneca's early development portfolio, which provides a translational medicine capability to rapidly understand the disease target and the potential of our candidate drugs in humans. At ECD you will work where science meet patients and you will be joining at an exciting time of respiratory drug discovery and development at AstraZeneca, where we have a number of innovative assets in the pipeline
As ADSM you will assist the Director(s) of Scientific Project Management (DSPMs) to fulfil their accountabilities through planning and leading the delivery of all components of an AstraZeneca sponsored clinical study (or group of clinical studies) from study design through study closeout activities. As ADSM you will also fulfil some clinical study coordination tasks or DSPM tasks depending on the nature of programme/delivery model. You will work with a high degree of flexibility and autonomy as the exact accountabilities will differ depending on the nature of the clinical programme. It is thus important to be able to interact directly with senior medical and project leadership staff without always going through an operational hierarchy.
Main Duties and Responsibilities
* Plan and Lead the delivery and reporting of all components of AstraZeneca sponsored clinical studies (internal ECD-led or outsourced studies) to time, quality, budget, project standards, company quality standards, and scientific requirements from Study Specifications/synopsis (SS) through Clinical Study Report
* Track and manage to agreed study timelines, budget, and resource and ensure the update of appropriate systems (e.g. IMPACT, OPAL)
* Liaise with Global Medicines Development (GMD) 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 AstraZeneca sponsored clinical studies
* Develop and manage contingency risk plans to assure timely delivery to quality and budget and escalate issues to stakeholders as appropriate
* Responsible for preparation and delivery of study documents (e.g. Protocols/amendments, documents detailing study delivery data management activities, etc.)
* 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
Essential Requirements
* University degree in relevant discipline, preferably in medical or biological science or discipline associated with clinical research.
* At least 5 years of experience in leading studies/programmes in clinical development
* Experience of working with and delivering through strategic partners and 3rd party vendors
* Proven leadership experience to drive project delivery
* Project Management experience within the context of Clinical Drug Development
* Excellent communication and collaboration skills, and ability to work with high degree of flexibility and autonomy
* Programme management qualification and experience from a variety of organisations and countries is a plus.
If you are interested, apply now!
For more information, please contact Barbara Valastro at
Welcome with your application no later than January 6th, 2019
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
Publiceringsdatum2018-12-10ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-01-07
Ange följande referens när du ansöker: R-040615
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
ulrica.marklund1@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4501962
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