Study Management Associate

Publicerad:
2018-11-07
Ort:
Göteborg, Västra Götalands län
Kategori:
Läkemedel, bioteknik & medicinteknik
Specialisering:
Övrigt
Omfattning:
Heltid
Jobbtyp:
Konsultuppdrag
Referensnummer:
201172431
Sista ansökningsdag:
2018-11-17
Kontakt:
Malin Wåhlberg
Do you have experience from drug development, good knowledge in ICH-GCP and also show good collaboration and interpersonal skills? This may be an interesting 6 months consultant assignment for you.

AstraZeneca is now recruiting a Study Management Associate (SMA) to join the Study Operations team within Early Clinical Development at AstraZeneca in Gothenburg, Sweden.

Early Clinical Development 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. Within Early Clinical Development the Study Operations organization is responsible for the delivery of planned clinical trials in accordance to agreed timelines.

As a SMA you will work close to Associate Directors Study Management and Senior Study Management associate and be responsible for coordinating activities that ensure quality, consistency, and integration of study data and clinical trial processes. The exact responsibilities will differ depending on the exact nature of the clinical program so a high degree of flexibility is required. The SMA is a global role and therefore you could work in studies within all therapeutic areas where AstraZeneca operates.

Main Duties and Responsibilities

  • Contribute to the development and update of study documents as well as review of SOPs and guidance documents
  • Lead the preparation of country specific agreements confidentiality agreements, clinical trial applications and other applicable country documents.
  • Ensuring the adequate and prompt supply of study materials and investigational products by liaising with Investigational Product Supply and external service providers as appropriate.
  • Maintain and close the TMF, ensuring continual inspection readiness
  • Support the study delivery team in the implementation of audits and regulatory inspections.
  • Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the Associate Director Study Management.
  • Interface with Investigators, third party vendors, Marketing Companies and internal staff to support effective delivery of a study and its regulatory documents
  • Initiate and maintain production of study documents, ensuring template and version compliance.
  • Provide input to data management, and interface with data management representatives and sites to facilitate the delivery of study data
  • Prepare presentation material for meetings, newsletters and web-sites
Essential Requirements

  • University degree in relevant discipline, preferably in medical or biological science, or discipline associated with Clinical Research or equivalent
  • Good understanding of the drug development process, study management, drug handling and data management
  • Experience of working with and delivering through strategic partners and 3rd party vendors
  • Excellent knowledge of ICH-GCP and basic knowledge of GMP/GDP
  • Fluent in written and spoken English
  • A clear demonstration of behaviors of: Ability to prioritize, flexibility, ability to manage multiple deliverables, team oriented, ability to manage change and actively seek and champion more efficient and effective methods/processes, good communication, negotiation, collaboration and interpersonal skills
Business: Dfind Science & Engineering

City: Gothenburg

Deadline for applications: 2018-11-17. Selection is on-going and interviews will be held continuously which means the position can be filled before deadline. Please make sure to send in your application at your earliest convenience!

For more information contact: Malin Wåhlberg mali.wahlberg@dfind.se or Birgitta Nyström birgitta.nystrom@dfind.se

Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.

Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.

Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world’s second largest company within recruiting and staffing.