Local Study Manager
AstraZeneca / Apotekarjobb / Södertälje
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SMM Nordic is part of the Development Operations in the global Research & Development (R&D) function. SMM executes and delivers clinical studies. Sweden contribute with a substantial part of the SMM Nordic delivery. Clinical studies are delivered in close collaboration with stakeholders in health care and academic medical institutions.
The LSM is responsible for leading the Local Study Team(s) (LSTs) at Nordic level to deliver committed components of global clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
In addition to leading LST(s), the Local Study Manager (LSM) may perform occasional site monitoring as needed to support the flexible capacity model. The LSM is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
In the Nordic 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. 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!
Our LSM team work flexible with base in Gärtuna, Södertälje in Sweden.
Essential accountabilities:
* Overall responsibility for the study commitments within the Nordic countries and for timely delivery of data to required quality
* Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
* Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations
* Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality
* Coordinates the site selection process by performing initial Site Quality Risk Assessment and conducting Site Qualification Visits to evaluate suitability and quality risks
* Submission of application/documents to EC/IRB
* Ensure delivery of application/documents for submissions to Regulatory Authority
* Ensures timely preparation of country financial Study Management Agreement and maintains accurate study budget in AZ clinical studies
* Preparation of local Master CSA (including site budget) and amendments as needed
* Preparation of country level Master Informed Consent Form and subsequent site level ICFs
* Ensures all essential documents required by ICH-GCP prior to study start have been collected
* Plans and coordinates applicable local drug activities
* Sets up and maintains the study in CTMS at study country level
* Oversees, manages and coordinates monitoring activities
* Reviews monitoring visit reports and proactively advice the monitor(s)
* Contributes to patient recruitment strategy
* Develops, maintains and reviews risk management plan on country study level
* Communicates and co-ordinates regularly with National Coordinating Investigator
* Plans and leads National Investigator meetings
* Forecasting study timelines, resources, recruitment, budget, study materials and drug supplies
* Ensures relevant systems required to facilitate business critical, license to operate activities (
* Ensures accurate payments related to the study are performed
* Participates in training and coaching new members of the Local Study Team
* Ensures completeness of the eTMF to maintain the eTMF "Inspection Ready"
Essential requirements:
* Bachelor degree in related discipline, preferably in life science, or equivalent qualification
* Minimum 3 years of experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies)
* Very good knowledge of international guidelines ICH-GCP as well as relevant local regulations
* Proven ability to lead and motivate cross-functional teams
* Excellent understanding of the Clinical Study Process including monitoring
* Very good understanding of the Study Drug Handling Process and the Data Management Process
* Integrity and high ethical standards
* organisational skills
* verbal and written communication skills (Swedish and English)
* ability to prioritize and handle multiple tasks
* negotiation skills
* analytical skills
* resource management skills
* decision making and delegation skills
* financial management skills
* change management skills
* coaching skills
* intercultural awareness
Ability to travel nationally and internationally as required.
If you are interested, please apply now!
For more information about the position please contact Anna Koch,
Welcome with your application no later than June 2nd, 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
Publiceringsdatum2019-05-13ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-05-23
Ange följande referens när du ansöker: R-050739
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
sara.jagevall@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
15185
15185 0181
KontorsadressAstraallén
Jobbnummer 4786960
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