Associate Director SMM - Clinical Operations
AstraZeneca AB / Chefsjobb / Södertälje
2019-12-18
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hela Sverige In the Nordic Site Management & Monitoring (SMM) team we have recently started a journey. We want to re-invent our organisation to find new and more effective ways of working in delivering our studies. We want each function to be accountable of their work and processes and every person counts. Are you seeing opportunities in change and get motivated by trying new ways? We need you, come be a part of our journey!
SMM Nordic is part of the Development Operations in the global Research & Development (R&D) function. SMM executes and delivers clinical studies. The clinical studies are delivered in close collaboration with stakeholders in health care and academic medical institutions. Our team works flexible with base in Gärtuna, Södertälje in Sweden. The ADSMM will be reporting to the Nordic Cluster Director (CDSMM), also located in Gärtuna.
The Associate Director SMM (ADSMM) is accountable for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP - as well as relevant local regulations. An important part will also be the responsibility for line managing dedicated group(s) of staff and responsible for planning and utilization of staff resources, assigned budget, objective setting and performance follow-up.
The role:
As Associate Director SMM (ADSMM) you will ensure that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. A great part of the role will be to manage and mentor a dedicated group - building the team spirit, developing team style and behavior. You will be responsible for the development and performance management of direct reports, ensure that the workload of direct reports is adequate and make sure that direct reports have development and training plans.
Main responsibilities:
* Contributes to high quality feasibility work and ensures collaboration with local Medical Affairs team.
* Oversees successful delivery of SMM study delivery country level targets to plan, with speed and quality.
* Contributes to the quality improvement of the study processes and other procedures. Supports SMM EU region in initiatives/activities as agreed with CD-SMM.
* Performs accompanied site visits according to local QC Plan, supporting ongoing coaching and development.
Essential requirements:
* Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (*).
* Minimum 5 years of experience in Development Operations (CRA / Sr. CRA / LSM) or other related fields.
* Proven experience in the Oncology field.
* Line management experience and excellent interpersonal skills.
* Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
* Great organisational, analytical, influencing and negotiation skills.
* Excellent knowledge of spoken and written English - both presentation and communication skills, verbal and written.
* Ability for national and international travel.
Desirable requirements:
* Very good knowledge of the Clinical Study Process and international ICH-GCP guidelines.
* Excellent knowledge of the Monitoring Process.
* Good understanding of the Study Drug Handling Process and the Data Management Process.
* Good knowledge of relevant local and international regulations.
* Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
* Ability to deliver quality according to the requested standards and ability to work according to global standards.
* Ability to work in an environment of remote collaborators and proven team building skills also in cross-functional teams.
If this sounds like the challenge for you - apply today!
For more information about the position please contact hiring manager Anna Koch (Cluster Director SMM Nordics) at .
We look forward to your application no later than January 19th, 2020.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-12-18ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2020-01-15
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-068884".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 5008998
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