Clinical Study Manager to a leading pharmaceutical mother company in the Stockholm area

We are looking for you who know that you have a qualified and attractive experience from work with managing clinical studies. You will be employed on a permanent position at Aktivia Science Work AB but will be placed and working on one of the most attractive pharmaceutical companies in Stockholm. Your employment will start after the summer vacations.

Main Assignments

  • Ensure knowledge of the patient´s medical need, current clinical landscape and operational feasibility by building relationships with investigators, study site personnel, other external parties and Sobi affiliates
  • Lead and manage the cross-functional clinical study team and supervise that the objectives and responsibilities within the team are fulfilled
  • Ensure delivery of all clinical study activities in accordance to agreed timelines, cost and quality, and delegation by the Clinical Program Leader
  • Risk manage the clinical study activities and deliverables
  • Ensure that clinical tracking tools and study contact lists are set-up and maintained throughout the clinical study
  • Ensure that study insurance documentation is valid according to current legislation
  • Forecast and manage the budget for individual clinical studies
  • Coordinate the clinical study activities with respect to Investigational Medicinal Products
  • Coordinate, contribute to and ensure delivery and filing of key clinical study documents such as clinical study protocols, protocol amendments, case report forms, patient information documents and clinical study reports
  • Ensure review and approval of key clinical study documents in accordance with Standard Operating Procedures (SOPs)
  • Identify External Service Providers (ESPs) for clinical study activities and deliverables together with the Clinical Outsourcing Manager and the clinical study team
  • Lead and manage ESPs appointed to perform the applicable clinical study activities and follow-up on ESP performance
  • Manage ESP contracts, amendments and change orders together with the Clinical Outsourcing Manager
  • Identify change of scope requirements to the ESP contracts
  • Coordinate the investigator/site selection process, and approve the selection of investigators/sites, as applicable
  • Oversee the progress of the clinical study and ensure that all clinical study activities and deliverables are compliant with SOPs, ICH/GCP guidelines and regulatory requirements
  • Provide clinical study status updates and escalate issues to the Clinical Program Leader
  • Ensure set-up, maintenance, completeness and archiving of the study master file
  • Contribute to the development of processes and tools to continuously improve resource utilization and quality of clinical study activities and deliverables

Your background

You have an education with in any relevant field within science, health care or other life science field. You have qualified experience of work with clinical trials managing most aspects of the clinical study work. You need to have experience from working with clinical CROs and management of clinical studies carried out in cooperation with CROs. There will be an advantage if you have experience from work at a mother company.

To apply

Please call Knut Natt och Dag on +46 722 16 68 00 if you want more information or want to discuss this recruitment project. Send your application containing a personal letter and CV to knut.nattochdag@aktivia.se. Write "CSM" in the subject field. We are working continuously with this recruitment project and would like to receive your application as soon as possible. 

Aktivia Science Work AB

Aktivia Science Work AB is a recruitment and staffing agency within Life Science. We are members of SwedenBIO and Medicon Valley Alliance. You can read more about us on our website - www.aktivia.se

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